Trial Outcomes & Findings for A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung (NCT NCT01218516)
NCT ID: NCT01218516
Last Updated: 2020-08-20
Results Overview
PFS was defined as the time from the date of randomization to the date of the first observation of investigator-assessed (radiology review) progression based on Response Evaluation Criteria In Solid Tumors (RECIST) v.1.1 or other protocol-approved measures of disease progression (e.g., new occurrence of positive fluid cytology, newly diagnosed evidence of disease progression from histologic samples, PET-positive metastases, or new bone or brain metastases), or date of death, whatever the cause. Disease progression as assessed by the investigator per RECIST v1.0 was defined as at least a 20% increase in sum of longest diameters (RECIST definition) compared to baseline (or lowest sum while on study if less than baseline), or any new lesions (measurable or nonmeasurable).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
130 participants
Primary outcome timeframe
From date of first administration of study drug up to 6 month follow-up from randomization of the last participant, i.e., cut-off date 15 Dec 2012 for primary analysis and cut-off date of 1 Nov 2013 or up to approximately 28 months for final analysis
Results posted on
2020-08-20
Participant Flow
All screening procedures were completed within 30 days prior to and including the Cycle 1 Day 1 Visit.
Participant milestones
| Measure |
Combination Therapy: Placebo + Chemotherapy
During Combination Therapy, placebo was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Duration of each cycle=3 weeks.
|
Combination Therapy: Farletuzumab + Chemotherapy
During Combination Therapy, farletuzumab was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Duration of each cycle=3 weeks.
|
Monotherapy: Placebo
Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Placebo + Chemotherapy) entered the Monotherapy phase and received placebo as monotherapy until disease progression. Duration of each cycle=3 weeks.
|
Monotherapy: Farletuzumab
Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Farletuzumab + Chemotherapy) entered the Monotherapy phase and received farletuzumab as monotherapy until disease progression. Duration of each cycle=3 weeks.
|
|---|---|---|---|---|
|
Combination Therapy (up to 4.5 Months)
STARTED
|
67
|
63
|
0
|
0
|
|
Combination Therapy (up to 4.5 Months)
COMPLETED
|
38
|
28
|
0
|
0
|
|
Combination Therapy (up to 4.5 Months)
NOT COMPLETED
|
29
|
35
|
0
|
0
|
|
Monotherapy (up to 23.5 Months)
STARTED
|
0
|
0
|
38
|
28
|
|
Monotherapy (up to 23.5 Months)
Safety Analysis Set
|
0
|
0
|
35
|
31
|
|
Monotherapy (up to 23.5 Months)
COMPLETED
|
0
|
0
|
38
|
28
|
|
Monotherapy (up to 23.5 Months)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Combination Therapy: Placebo + Chemotherapy
During Combination Therapy, placebo was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Duration of each cycle=3 weeks.
|
Combination Therapy: Farletuzumab + Chemotherapy
During Combination Therapy, farletuzumab was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Duration of each cycle=3 weeks.
|
Monotherapy: Placebo
Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Placebo + Chemotherapy) entered the Monotherapy phase and received placebo as monotherapy until disease progression. Duration of each cycle=3 weeks.
|
Monotherapy: Farletuzumab
Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Farletuzumab + Chemotherapy) entered the Monotherapy phase and received farletuzumab as monotherapy until disease progression. Duration of each cycle=3 weeks.
|
|---|---|---|---|---|
|
Combination Therapy (up to 4.5 Months)
Death
|
2
|
1
|
0
|
0
|
|
Combination Therapy (up to 4.5 Months)
Delay in TA Administration of >=28 days
|
0
|
3
|
0
|
0
|
|
Combination Therapy (up to 4.5 Months)
Physician Decision
|
2
|
2
|
0
|
0
|
|
Combination Therapy (up to 4.5 Months)
Chemotherapy Discontinued
|
2
|
0
|
0
|
0
|
|
Combination Therapy (up to 4.5 Months)
Progressive Disease (PD) by RECIST v 1.1
|
17
|
15
|
0
|
0
|
|
Combination Therapy (up to 4.5 Months)
Randomized but Not Treated
|
0
|
1
|
0
|
0
|
|
Combination Therapy (up to 4.5 Months)
Withdrew Consent
|
0
|
1
|
0
|
0
|
|
Combination Therapy (up to 4.5 Months)
Deterioration of Performance Status
|
0
|
3
|
0
|
0
|
|
Combination Therapy (up to 4.5 Months)
Other
|
3
|
4
|
0
|
0
|
|
Combination Therapy (up to 4.5 Months)
Toxicity to TA
|
0
|
1
|
0
|
0
|
|
Combination Therapy (up to 4.5 Months)
Participant Discontinued Treatment
|
2
|
3
|
0
|
0
|
|
Combination Therapy (up to 4.5 Months)
Treatment With Items Outside Protocol
|
1
|
1
|
0
|
0
|
Baseline Characteristics
A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung
Baseline characteristics by cohort
| Measure |
Combination Therapy: Placebo + Chemotherapy
n=67 Participants
During Combination Therapy, placebo was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Duration of each cycle=3 weeks.
|
Combination Therapy: Farletuzumab + Chemotherapy
n=63 Participants
During Combination Therapy, farletuzumab was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Duration of each cycle=3 weeks.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.0 Years
n=5 Participants
|
60.0 Years
n=7 Participants
|
61.0 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of first administration of study drug up to 6 month follow-up from randomization of the last participant, i.e., cut-off date 15 Dec 2012 for primary analysis and cut-off date of 1 Nov 2013 or up to approximately 28 months for final analysisPopulation: The ITT population included all randomized participants who received at least 1 dose of test article (placebo or farletuzumab), with treatment assignments designated according to actual study treatment received. This was the primary analysis population for evaluating treatment administration, tolerability, and safety.
PFS was defined as the time from the date of randomization to the date of the first observation of investigator-assessed (radiology review) progression based on Response Evaluation Criteria In Solid Tumors (RECIST) v.1.1 or other protocol-approved measures of disease progression (e.g., new occurrence of positive fluid cytology, newly diagnosed evidence of disease progression from histologic samples, PET-positive metastases, or new bone or brain metastases), or date of death, whatever the cause. Disease progression as assessed by the investigator per RECIST v1.0 was defined as at least a 20% increase in sum of longest diameters (RECIST definition) compared to baseline (or lowest sum while on study if less than baseline), or any new lesions (measurable or nonmeasurable).
Outcome measures
| Measure |
Combination Therapy: Placebo + Chemotherapy
n=67 Participants
During Combination Therapy, placebo was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Duration of each cycle=3 weeks.
|
Combination Therapy: Farletuzumab + Chemotherapy
n=63 Participants
During Combination Therapy, farletuzumab was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Duration of each cycle=3 weeks.
|
Monotherapy: Placebo
Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Placebo + Chemotherapy) entered the Monotherapy phase and received placebo as monotherapy until disease progression. Duration of each cycle=3 weeks.
|
Monotherapy: Farletuzumab
Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Farletuzumab + Chemotherapy) entered the Monotherapy phase and received farletuzumab as monotherapy until disease progression. Duration of each cycle=3 weeks.
|
|---|---|---|---|---|
|
Progression-free Survival (PFS)
Per Primary Analysis Cut-Off Date
|
5.8 Months
Interval 5.0 to 6.8
|
4.7 Months
Interval 4.2 to 5.6
|
—
|
—
|
|
Progression-free Survival (PFS)
Per Final Analysis Cut-Off Date
|
5.9 Months
Interval 5.0 to 7.0
|
4.7 Months
Interval 4.2 to 5.6
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 until documented radiographic progression, other protocol-approved measures of disease progression, withdrawal by participant, death due to any cause, or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysisPopulation: The ITT population included all randomized participants who received at least 1 dose of test article (placebo or farletuzumab), with treatment assignments designated according to actual study treatment received. This was the primary analysis population for evaluating treatment administration, tolerability, and safety.
ORR, defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator's radiologic assessments using RECIST 1.1 for target lesions and assessed by Magnetic resonance imaging (MRI) and computerized tomography (CT) scan (for double blind treatment period i.e. Randomization Phase). CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.
Outcome measures
| Measure |
Combination Therapy: Placebo + Chemotherapy
n=67 Participants
During Combination Therapy, placebo was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Duration of each cycle=3 weeks.
|
Combination Therapy: Farletuzumab + Chemotherapy
n=63 Participants
During Combination Therapy, farletuzumab was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Duration of each cycle=3 weeks.
|
Monotherapy: Placebo
Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Placebo + Chemotherapy) entered the Monotherapy phase and received placebo as monotherapy until disease progression. Duration of each cycle=3 weeks.
|
Monotherapy: Farletuzumab
Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Farletuzumab + Chemotherapy) entered the Monotherapy phase and received farletuzumab as monotherapy until disease progression. Duration of each cycle=3 weeks.
|
|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
37.3 Percentage of participants
|
41.3 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first documentation of objective response (CR or PR) to the first documentation of disease progression, death due to any cause, or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysisPopulation: Tumor Response (TR) Evaluable Analysis Set (responders only) included all participants who received at least 1 dose of test article and who had a baseline assessment and at least 1 on-treatment assessment performed, sufficient to assess the endpoint of interest. The TR Evaluable Analysis Set was used for all RECIST assessments of tumor response.
DR was derived for those participants with objective evidence of CR or PR. DR was defined as the time (in months) from first documentation of objective response (CR or PR) to the first documentation of disease progression (ie, objective tumor progression as assessed by investigator's radiology review or other protocol-approved measures of disease progression) or death due to any cause. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Combination Therapy: Placebo + Chemotherapy
n=25 Participants
During Combination Therapy, placebo was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Duration of each cycle=3 weeks.
|
Combination Therapy: Farletuzumab + Chemotherapy
n=25 Participants
During Combination Therapy, farletuzumab was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Duration of each cycle=3 weeks.
|
Monotherapy: Placebo
Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Placebo + Chemotherapy) entered the Monotherapy phase and received placebo as monotherapy until disease progression. Duration of each cycle=3 weeks.
|
Monotherapy: Farletuzumab
Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Farletuzumab + Chemotherapy) entered the Monotherapy phase and received farletuzumab as monotherapy until disease progression. Duration of each cycle=3 weeks.
|
|---|---|---|---|---|
|
Duration of Response (DR)
|
6.7 Months
Interval 4.1 to 9.4
|
4.1 Months
Interval 3.0 to 7.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of death due to any cause or up to cut-off date of 1 Nov 2013 (up to approximately 28 months) for final analysisPopulation: The ITT population included all randomized participants who received at least 1 dose of test article (placebo or farletuzumab), with treatment assignments designated according to actual study treatment received. This was the primary analysis population for evaluating treatment administration, tolerability, and safety.
OS was defined as the time (in months) from the date of randomization to the date of death, regardless of cause.
Outcome measures
| Measure |
Combination Therapy: Placebo + Chemotherapy
n=67 Participants
During Combination Therapy, placebo was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Duration of each cycle=3 weeks.
|
Combination Therapy: Farletuzumab + Chemotherapy
n=63 Participants
During Combination Therapy, farletuzumab was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Duration of each cycle=3 weeks.
|
Monotherapy: Placebo
Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Placebo + Chemotherapy) entered the Monotherapy phase and received placebo as monotherapy until disease progression. Duration of each cycle=3 weeks.
|
Monotherapy: Farletuzumab
Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Farletuzumab + Chemotherapy) entered the Monotherapy phase and received farletuzumab as monotherapy until disease progression. Duration of each cycle=3 weeks.
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
10.5 Months
Interval 8.3 to 14.0
|
14.1 Months
Interval 9.5 to 18.6
|
—
|
—
|
SECONDARY outcome
Timeframe: For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysisPopulation: The safety analysis set (SAS) included randomized participants who received at least 1 dose of test article, with treatment assignments designated according to actual study treatment received. This was the primary analysis population for evaluating treatment administration, tolerability, and safety.
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (i.e., the participant was at a risk of death at the time of the event; this did not include an event that hypothetically might have caused death if it had been more severe), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, or was a congenital abnormality/birth defect. In this study, TEAEs (defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Outcome measures
| Measure |
Combination Therapy: Placebo + Chemotherapy
n=65 Participants
During Combination Therapy, placebo was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Duration of each cycle=3 weeks.
|
Combination Therapy: Farletuzumab + Chemotherapy
n=64 Participants
During Combination Therapy, farletuzumab was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Duration of each cycle=3 weeks.
|
Monotherapy: Placebo
n=35 Participants
Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Placebo + Chemotherapy) entered the Monotherapy phase and received placebo as monotherapy until disease progression. Duration of each cycle=3 weeks.
|
Monotherapy: Farletuzumab
n=31 Participants
Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Farletuzumab + Chemotherapy) entered the Monotherapy phase and received farletuzumab as monotherapy until disease progression. Duration of each cycle=3 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)
TEAEs
|
60 Participants
|
63 Participants
|
30 Participants
|
25 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)
Treatment emergent SAEs
|
27 Participants
|
27 Participants
|
6 Participants
|
7 Participants
|
Adverse Events
Combination Therapy: Placebo + Chemotherapy
Serious events: 27 serious events
Other events: 60 other events
Deaths: 46 deaths
Combination Therapy: Farletuzumab + Chemotherapy
Serious events: 27 serious events
Other events: 63 other events
Deaths: 39 deaths
Monotherapy: Placebo
Serious events: 6 serious events
Other events: 30 other events
Deaths: 1 deaths
Monotherapy: Farletuzumab
Serious events: 7 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Combination Therapy: Placebo + Chemotherapy
n=65 participants at risk
During Combination Therapy, placebo was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Duration of each cycle=3 weeks.
|
Combination Therapy: Farletuzumab + Chemotherapy
n=64 participants at risk
During Combination Therapy, farletuzumab was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Duration of each cycle=3 weeks.
|
Monotherapy: Placebo
n=35 participants at risk
Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Placebo + Chemotherapy) entered the Monotherapy phase and received placebo as monotherapy until disease progression. Duration of each cycle=3 weeks.
|
Monotherapy: Farletuzumab
n=31 participants at risk
Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Farletuzumab + Chemotherapy) entered the Monotherapy phase and received farletuzumab as monotherapy until disease progression. Duration of each cycle=3 weeks.
|
|---|---|---|---|---|
|
Vascular disorders
Deep vein thrombosis
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Vascular disorders
Hypertension
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Vascular disorders
Superior vena cava syndrome
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Small Cell Lung Cancer
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Immune system disorders
Hypersensitivity
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Pyrexia
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.1%
2/64 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.5%
2/31 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
General physical health deterioration
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.1%
2/64 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Asthenia
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Death
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Disease Progression
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Localised oedema
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Oedema peripheral
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Gait disturbance
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Psychiatric disorders
Confusional state
|
3.1%
2/65 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Psychiatric disorders
Hallucination, auditory
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Psychiatric disorders
Hallucination, visual
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Investigations
Weight decreased
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Investigations
International normalised ratio increased
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Cardiac disorders
Atrial fibrillation
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Cardiac disorders
Pericardial effusion
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.7%
5/65 • Number of events 5 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
4.7%
3/64 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.1%
2/64 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.1%
2/64 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.1%
2/64 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.5%
1/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Cerebral infarction
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Dysaesthesia
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Encephalitis
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Sciatica
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Eye disorders
Diplopia
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
4.7%
3/64 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.1%
2/64 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Ileal perforation
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Renal and urinary disorders
Renal failure
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
4.7%
3/64 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Pneumonia
|
4.6%
3/65 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.5%
2/31 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Empyema
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Encephalitic infection
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
Other adverse events
| Measure |
Combination Therapy: Placebo + Chemotherapy
n=65 participants at risk
During Combination Therapy, placebo was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Duration of each cycle=3 weeks.
|
Combination Therapy: Farletuzumab + Chemotherapy
n=64 participants at risk
During Combination Therapy, farletuzumab was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Duration of each cycle=3 weeks.
|
Monotherapy: Placebo
n=35 participants at risk
Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Placebo + Chemotherapy) entered the Monotherapy phase and received placebo as monotherapy until disease progression. Duration of each cycle=3 weeks.
|
Monotherapy: Farletuzumab
n=31 participants at risk
Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Farletuzumab + Chemotherapy) entered the Monotherapy phase and received farletuzumab as monotherapy until disease progression. Duration of each cycle=3 weeks.
|
|---|---|---|---|---|
|
Investigations
C-Reactive protein increased
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Vascular disorders
Deep vein thrombosis
|
6.2%
4/65 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
4.7%
3/64 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
5.7%
2/35 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Asthenia
|
18.5%
12/65 • Number of events 13 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
34.4%
22/64 • Number of events 32 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
8.6%
3/35 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.5%
2/31 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Fatigue
|
44.6%
29/65 • Number of events 48 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
37.5%
24/64 • Number of events 29 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
8.6%
3/35 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Pyrexia
|
9.2%
6/65 • Number of events 8 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
14.1%
9/64 • Number of events 15 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.5%
2/31 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Mucosal inflammation
|
13.8%
9/65 • Number of events 15 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
10.9%
7/64 • Number of events 7 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Oedema peripheral
|
7.7%
5/65 • Number of events 5 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
9.4%
6/64 • Number of events 8 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
8.6%
3/35 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Chills
|
4.6%
3/65 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.2%
4/64 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
General physical health deterioration
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
4.7%
3/64 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Non-cardiac chest pain
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
4.7%
3/64 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Psychiatric disorders
Insomnia
|
7.7%
5/65 • Number of events 6 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
9.4%
6/64 • Number of events 6 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.5%
2/31 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Psychiatric disorders
Anxiety
|
3.1%
2/65 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
10.9%
7/64 • Number of events 7 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Psychiatric disorders
Confusional state
|
7.7%
5/65 • Number of events 5 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Investigations
Weight decreased
|
4.6%
3/65 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.2%
4/64 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Investigations
Blood creatinine increased
|
4.6%
3/65 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Blood and lymphatic system disorders
Anaemia
|
30.8%
20/65 • Number of events 24 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
37.5%
24/64 • Number of events 27 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
11.4%
4/35 • Number of events 5 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Blood and lymphatic system disorders
Neutropenia
|
15.4%
10/65 • Number of events 18 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
34.4%
22/64 • Number of events 34 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.8%
7/65 • Number of events 11 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
12.5%
8/64 • Number of events 9 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.6%
3/65 • Number of events 6 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.2%
4/64 • Number of events 6 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.7%
5/65 • Number of events 5 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
4.7%
3/64 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.3%
8/65 • Number of events 8 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
18.8%
12/64 • Number of events 15 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
17.1%
6/35 • Number of events 6 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
9.7%
3/31 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
10/65 • Number of events 11 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
14.1%
9/64 • Number of events 14 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
11.4%
4/35 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
19.4%
6/31 • Number of events 6 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
7.8%
5/64 • Number of events 5 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
9.7%
3/31 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
4/65 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
9.4%
6/64 • Number of events 6 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.6%
3/65 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
4.7%
3/64 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.5%
2/31 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.2%
4/64 • Number of events 5 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
4.7%
3/64 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.6%
3/65 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.1%
2/64 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.5%
2/31 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Dizziness
|
9.2%
6/65 • Number of events 6 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
12.5%
8/64 • Number of events 10 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.5%
2/31 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Headache
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
4.7%
3/64 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
16.1%
5/31 • Number of events 5 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Paraesthesia
|
12.3%
8/65 • Number of events 9 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
9.4%
6/64 • Number of events 7 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
5.7%
2/35 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Dysgeusia
|
7.7%
5/65 • Number of events 5 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
4.7%
3/64 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Neuropathy peripheral
|
9.2%
6/65 • Number of events 6 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
4.7%
3/64 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Polyneuropathy
|
4.6%
3/65 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.2%
4/64 • Number of events 5 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Eye disorders
Conjunctivitis
|
7.7%
5/65 • Number of events 11 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
4.7%
3/64 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.2%
4/64 • Number of events 5 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Nausea
|
46.2%
30/65 • Number of events 48 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
45.3%
29/64 • Number of events 43 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.5%
2/31 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Constipation
|
27.7%
18/65 • Number of events 26 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
31.2%
20/64 • Number of events 27 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
8.6%
3/35 • Number of events 6 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.5%
2/31 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Diarrhoea
|
24.6%
16/65 • Number of events 22 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
28.1%
18/64 • Number of events 21 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
5.7%
2/35 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Vomiting
|
24.6%
16/65 • Number of events 33 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
25.0%
16/64 • Number of events 25 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Stomatitis
|
10.8%
7/65 • Number of events 11 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
9.4%
6/64 • Number of events 8 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.2%
4/64 • Number of events 5 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.1%
2/64 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
5.7%
2/35 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.5%
2/31 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.7%
5/65 • Number of events 5 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
4/65 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
12.5%
8/64 • Number of events 9 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.7%
5/65 • Number of events 7 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.2%
4/64 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.5%
2/31 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
4/65 • Number of events 5 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
4.7%
3/64 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
4/65 • Number of events 5 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
4.7%
3/64 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
14.1%
9/64 • Number of events 11 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.2%
6/65 • Number of events 6 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
12.5%
8/64 • Number of events 11 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
11.4%
4/35 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.8%
7/65 • Number of events 8 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
10.9%
7/64 • Number of events 8 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
5.7%
2/35 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.1%
2/65 • Number of events 5 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
7.8%
5/64 • Number of events 8 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.5%
2/31 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
4.7%
3/64 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
8.6%
3/35 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.2%
4/65 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
8.6%
3/35 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.5%
2/31 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
21.5%
14/65 • Number of events 21 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
26.6%
17/64 • Number of events 19 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
5.7%
2/35 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.6%
3/65 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
12.5%
8/64 • Number of events 10 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
9.2%
6/65 • Number of events 6 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
10.9%
7/64 • Number of events 8 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.2%
4/65 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
7.8%
5/64 • Number of events 6 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
7.8%
5/64 • Number of events 5 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.8%
7/65 • Number of events 7 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Pneumonia
|
10.8%
7/65 • Number of events 7 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
4.7%
3/64 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
5.7%
2/35 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.5%
2/31 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
4/65 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
4.7%
3/64 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
8.6%
3/35 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.5%
2/31 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
4/65 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.2%
4/64 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Localised oedema
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.1%
2/64 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Pain
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.1%
2/64 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Axillary pain
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Chest discomfort
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Chest pain
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Death
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Disease progression
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Face oedema
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Feeling cold
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Influenza like illness
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Infusion site urticaria
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Mucosal dryness
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Catheter site pain
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Device occlusion
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Gait disturbance
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Infusion site reaction
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Injection site reaction
|
1.5%
1/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Malaise
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Performance status decreased
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Dysphagia
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.1%
2/64 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.1%
2/64 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.6%
3/65 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Ileal perforation
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Tongue coated
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Flatulence
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Oral pain
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
1.5%
1/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Metabolism and nutrition disorders
Fluid overload
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.1%
2/64 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.1%
2/64 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
5.7%
2/35 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
4.7%
3/64 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
5.7%
2/35 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.5%
2/31 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.5%
1/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
5.7%
2/35 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.5%
2/31 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.6%
3/65 • Number of events 5 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
9.7%
3/31 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Aphonia
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Dystonia
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Balance disorder
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Cerebral cyst
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Cerebral infarction
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Cognitive disorder
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Depressed level of consciousness
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Dysaesthesia
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Encephalitis
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Encephalopathy
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Lethargy
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Memory impairment
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Paresis
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Sciatica
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Somnolence
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Syncope
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Tremor
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
4.7%
3/64 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
4.7%
3/64 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
4.7%
3/64 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
4.7%
3/64 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Skin and subcutaneous tissue disorders
Capillaritis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
4.6%
3/65 • Number of events 6 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Bronchitis
|
4.6%
3/65 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.1%
2/64 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Candidiasis
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.1%
2/64 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Abdominal Sepsis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Herpes dermatitis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Oral candidiasis
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Otitis media
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Skin infection
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Cellulitis
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Clostridial infection
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Conjunctivitis infective
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Cystitis
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Encephalitic Infection
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Fungal infection
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Gastroenteritis
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Lower respiratory tract infection
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Onychomycosis
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Pneumonia streptococcal
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Respiratory tract infection
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Respiratory tract infection fungal
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Septic shock
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Tooth abscess
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Psychiatric disorders
Depression
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Psychiatric disorders
Hallucination, auditory
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Psychiatric disorders
Hallucination, visual
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Psychiatric disorders
Panic attack
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Psychiatric disorders
Restlessness
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Vascular disorders
Hypertension
|
3.1%
2/65 • Number of events 5 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
4.7%
3/64 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
5.7%
2/35 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Vascular disorders
Hot flush
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Vascular disorders
Hypotension
|
3.1%
2/65 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Vascular disorders
Orthostatic hypotension
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Vascular disorders
Superior vena cava syndrome
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Vascular disorders
Thrombophlebitis
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Vascular disorders
Venous occlusion
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Eye disorders
Eye irritation
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.1%
2/64 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Eye disorders
Visual acuity reduced
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.1%
2/64 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Eye disorders
Dry eye
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Eye disorders
Eye pruritus
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Eye disorders
Photopsia
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Eye disorders
Visual impairment
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Eye disorders
Diplopia
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Eye disorders
Vision blurred
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Investigations
Alanine aminotransferase increased
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
4.7%
3/64 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Investigations
Aspartate aminotransferase increased
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Investigations
International normalised ratio increased
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Investigations
Blood pressure increased
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Investigations
Weight increased
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.1%
2/64 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Ear and labyrinth disorders
Deafness
|
1.5%
1/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Ear and labyrinth disorders
Vertigo
|
3.1%
2/65 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.1%
2/64 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Injury, poisoning and procedural complications
Laceration
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Renal and urinary disorders
Renal failure
|
4.6%
3/65 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.1%
2/64 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Renal and urinary disorders
Urinary incontinence
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Renal and urinary disorders
Dysuria
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Renal and urinary disorders
Haematuria
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Renal and urinary disorders
Oliguria
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Renal and urinary disorders
Pollakiuria
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Renal and urinary disorders
Proteinuria
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Renal and urinary disorders
Renal impairment
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Cardiac disorders
Pericardial effusion
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Cardiac disorders
Tachycardia
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Cardiac disorders
Angina pectoris
|
1.5%
1/65 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Cardiac disorders
Atrial fibrillation
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Cardiac disorders
Atrial flutter
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Cardiac disorders
Bradycardia
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Congenital, familial and genetic disorders
Renal fusion anomaly
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
1.6%
1/64 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Immune system disorders
Hypersensitivity
|
1.5%
1/65 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Furuncle
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Influenza
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Lymph gland infection
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
General disorders
Oedema
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Investigations
Breath sounds abnormal
|
3.1%
2/65 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Investigations
Blood urea increased
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
6.5%
2/31 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
2.9%
1/35 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Infections and infestations
Empyema
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/35 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
3.2%
1/31 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To central nervous system
|
0.00%
0/65 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/64 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
5.7%
2/35 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
0.00%
0/31 • For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
|
Additional Information
Morphotek (subsidiary of Eisai)
Morphotek (subsidiary of Eisai)
Phone: 1-888-422-4743
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place