Trial Outcomes & Findings for Chemotherapy Plus Cetuximab in Combination With VTX-2337 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (NCT NCT01836029)
NCT ID: NCT01836029
Last Updated: 2019-10-29
Results Overview
PFS was based on central assessment by a blinded independent radiologist per immune related response evaluation criteria for solid tumors (irRECIST) and was summarized and displayed by treatment arm using Kaplan-Meier methods. Treatments were compared using a stratified log-rank test controlling for randomization stratification factors. The hazard ratio between the 2 treatment arms, as well as the associated one-sided 90% CI and p-value, were presented using a Cox proportional hazards regression model.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
195 participants
Primary outcome timeframe
PFS is the time from randomization until disease progression or death, whichever comes first.
Results posted on
2019-10-29
Participant Flow
Participant milestones
| Measure |
Chemotherapy and Cetuximab Plus VTX-2337
VTX-2337 (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. VTX-2337: TLR8 Agonist Carboplatin Cisplatin 5-fluorouracil
|
Chemotherapy and Cetuximab Plus Placebo
Placebo (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. Carboplatin Cisplatin 5-fluorouracil Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
95
|
|
Overall Study
COMPLETED
|
100
|
95
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chemotherapy Plus Cetuximab in Combination With VTX-2337 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Baseline characteristics by cohort
| Measure |
Chemotherapy and Cetuximab Plus VTX-2337
n=100 Participants
VTX-2337 (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. VTX-2337: TLR8 Agonist Carboplatin Cisplatin 5-fluorouracil
|
Chemotherapy and Cetuximab Plus Placebo
n=95 Participants
Placebo (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. Carboplatin Cisplatin 5-fluorouracil Placebo
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 10.07 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 9.08 • n=7 Participants
|
58.5 years
STANDARD_DEVIATION 9.68 • n=5 Participants
|
|
Age, Customized
<40 years
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
47 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
29 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Customized
>=80 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
81 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
100 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: PFS is the time from randomization until disease progression or death, whichever comes first.Population: ITT population
PFS was based on central assessment by a blinded independent radiologist per immune related response evaluation criteria for solid tumors (irRECIST) and was summarized and displayed by treatment arm using Kaplan-Meier methods. Treatments were compared using a stratified log-rank test controlling for randomization stratification factors. The hazard ratio between the 2 treatment arms, as well as the associated one-sided 90% CI and p-value, were presented using a Cox proportional hazards regression model.
Outcome measures
| Measure |
Chemotherapy and Cetuximab Plus VTX-2337
n=100 Participants
VTX-2337 (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. VTX-2337: TLR8 Agonist Carboplatin Cisplatin 5-fluorouracil
|
Chemotherapy and Cetuximab Plus Placebo
n=95 Participants
Placebo (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. Carboplatin Cisplatin 5-fluorouracil Placebo
|
|---|---|---|
|
Comparison of Progression Free Survival (PFS) Between Treatment Groups Using irRECIST and Evaluated by Independent Radiology.
|
185 days
Interval 182.0 to
The upper bound of the confidence interval could not be calculated.
|
181 days
Interval 180.0 to
The upper bound of the confidence interval could not be calculated.
|
SECONDARY outcome
Timeframe: AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. Overall mean duration of exposure was 25.3 weeks.Population: Safety population: subjects who received at least 1 dose of VTX-2337 or placebo.
The frequency and severity of adverse events, including any clinically significant changes in physical exam, laboratory values, or other clinical assessment.
Outcome measures
| Measure |
Chemotherapy and Cetuximab Plus VTX-2337
n=89 Participants
VTX-2337 (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. VTX-2337: TLR8 Agonist Carboplatin Cisplatin 5-fluorouracil
|
Chemotherapy and Cetuximab Plus Placebo
n=86 Participants
Placebo (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. Carboplatin Cisplatin 5-fluorouracil Placebo
|
|---|---|---|
|
Comparison of Adverse Events (AEs) Between the Two Treatment Groups.
Subjects with TEAE
|
100 percentage of participants
|
100 percentage of participants
|
|
Comparison of Adverse Events (AEs) Between the Two Treatment Groups.
Subjects with Grade 3 and above TEAE
|
84.3 percentage of participants
|
83.7 percentage of participants
|
|
Comparison of Adverse Events (AEs) Between the Two Treatment Groups.
Subjects with serious TEAE
|
39.3 percentage of participants
|
39.5 percentage of participants
|
|
Comparison of Adverse Events (AEs) Between the Two Treatment Groups.
Subjects with TEAE with outcome of death
|
4.5 percentage of participants
|
8.1 percentage of participants
|
|
Comparison of Adverse Events (AEs) Between the Two Treatment Groups.
Subjects discontinued treatment due to TEAE
|
19.1 percentage of participants
|
18.6 percentage of participants
|
SECONDARY outcome
Timeframe: OS is the time from randomization until death due to any cause or the date last confirmed to be alive.Population: ITT population
Estimated using Kaplan-Meier product limit estimates, 1-sided stratified log-rank test, and Cox proportional hazard model; all with 90% 1-sided confidence intervals.
Outcome measures
| Measure |
Chemotherapy and Cetuximab Plus VTX-2337
n=100 Participants
VTX-2337 (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. VTX-2337: TLR8 Agonist Carboplatin Cisplatin 5-fluorouracil
|
Chemotherapy and Cetuximab Plus Placebo
n=95 Participants
Placebo (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. Carboplatin Cisplatin 5-fluorouracil Placebo
|
|---|---|---|
|
Comparison of Overall Survival (OS) Between the 2 Treatment Groups.
|
412 days
Interval 359.0 to
The upper bound of the confidence interval could not be calculated.
|
343 days
Interval 319.0 to
The upper bound of the confidence interval could not be calculated.
|
SECONDARY outcome
Timeframe: From the time of randomization until the best response on treatment is documented.Population: ITT population
Objective response rate is defined as the percentage of subjects who achieve best overall response of irCR or irPR pr irRECIST and evaluated by independent radiology..
Outcome measures
| Measure |
Chemotherapy and Cetuximab Plus VTX-2337
n=100 Participants
VTX-2337 (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. VTX-2337: TLR8 Agonist Carboplatin Cisplatin 5-fluorouracil
|
Chemotherapy and Cetuximab Plus Placebo
n=95 Participants
Placebo (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. Carboplatin Cisplatin 5-fluorouracil Placebo
|
|---|---|---|
|
Comparison of the Objective Response Rate Between the Two Treatment Groups p
|
38.0 percentage of participants
|
33.7 percentage of participants
|
Adverse Events
Chemotherapy and Cetuximab Plus VTX-2337
Serious events: 35 serious events
Other events: 89 other events
Deaths: 0 deaths
Chemotherapy and Cetuximab Plus Placebo
Serious events: 34 serious events
Other events: 86 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chemotherapy and Cetuximab Plus VTX-2337
n=89 participants at risk
VTX-2337 (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. VTX-2337: TLR8 Agonist Carboplatin Cisplatin 5-fluorouracil
|
Chemotherapy and Cetuximab Plus Placebo
n=86 participants at risk
Placebo (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. Carboplatin Cisplatin 5-fluorouracil Placebo
|
|---|---|---|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Infections and infestations
Pneumonia
|
5.6%
5/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
5.8%
5/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.9%
7/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
2.3%
2/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
5/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
4.7%
4/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
vomitting
|
5.6%
5/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
3.5%
3/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
Nausea
|
4.5%
4/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
2.3%
2/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Infections and infestations
Sepsis
|
2.2%
2/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
4.7%
4/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Infections and infestations
Lung infection
|
3.4%
3/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary emolism
|
3.4%
3/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
2.3%
2/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.2%
2/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
2.3%
2/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Vascular disorders
Hypotension
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
4.7%
4/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
General disorders
Fatigue
|
2.2%
2/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
2.3%
2/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.2%
2/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.4%
3/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
2.3%
2/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.2%
2/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
2.3%
2/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.4%
3/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
4.7%
4/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Cardiac disorders
Acute coronary syndrome
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Cardiac disorders
Palpitations
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
Melaena
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
2.3%
2/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
General disorders
Asthenia
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
General disorders
Death
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
2.3%
2/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
General disorders
Medical device complication
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
General disorders
Pain
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
2.3%
2/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
General disorders
Pyrexia
|
3.4%
3/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Immune system disorders
Anaphylactic reaction
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Immune system disorders
Cytokine release syndrome
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Infections and infestations
Acinetobacter bacteraemia
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Infections and infestations
Bacteraemia
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Infections and infestations
Device related infection
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Infections and infestations
Infection
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
2.3%
2/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Infections and infestations
Soft tissue infection
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Infections and infestations
Staphylococcal infection
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Infections and infestations
Staphylococcal sepsis
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Injury, poisoning and procedural complications
Feeding tube complication
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Injury, poisoning and procedural complications
Radiation mucositis
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Investigations
Occult blood positive
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
2.3%
2/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Metabolism and nutrition disorders
Metabolic syndrome
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
2.3%
2/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Nervous system disorders
Headache
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
2.3%
2/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Psychiatric disorders
Mental status changes
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
2.3%
2/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.2%
2/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
2.3%
2/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Surgical and medical procedures
Wound treatment
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Vascular disorders
Embolism
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
1.2%
1/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Vascular disorders
Vena cava thrombosis
|
1.1%
1/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
Other adverse events
| Measure |
Chemotherapy and Cetuximab Plus VTX-2337
n=89 participants at risk
VTX-2337 (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. VTX-2337: TLR8 Agonist Carboplatin Cisplatin 5-fluorouracil
|
Chemotherapy and Cetuximab Plus Placebo
n=86 participants at risk
Placebo (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. Carboplatin Cisplatin 5-fluorouracil Placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
59.6%
53/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
45.3%
39/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
42.7%
38/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
33.7%
29/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
11.2%
10/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
10.5%
9/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
56.2%
50/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
52.3%
45/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
56.2%
50/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
50.0%
43/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Cardiac disorders
Tachycardia
|
9.0%
8/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
4.7%
4/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
Constipation
|
33.7%
30/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
26.7%
23/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
31.5%
28/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
30.2%
26/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
2.2%
2/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
10.5%
9/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.9%
7/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
5.8%
5/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
12.4%
11/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
17.4%
15/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.2%
2/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
8.1%
7/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
Nausea
|
40.4%
36/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
33.7%
29/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
Oral pain
|
5.6%
5/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
5.8%
5/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
38.2%
34/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
48.8%
42/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Gastrointestinal disorders
Vomiting
|
36.0%
32/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
27.9%
24/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
General disorders
Asthenia
|
4.5%
4/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
7.0%
6/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
General disorders
Chills
|
37.1%
33/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
5.8%
5/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
General disorders
Fatigue
|
42.7%
38/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
45.3%
39/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
General disorders
Influenza like illness
|
14.6%
13/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
3.5%
3/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
General disorders
Injection site reactions
|
39.3%
35/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
0.00%
0/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
General disorders
Pain
|
4.5%
4/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
7.0%
6/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
General disorders
Pyrexia
|
42.7%
38/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
11.6%
10/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Immune system disorders
Cytokine release syndrome
|
7.9%
7/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
3.5%
3/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Infections and infestations
Paronychia
|
9.0%
8/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
11.6%
10/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Infections and infestations
Pneumonia
|
9.0%
8/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
8.1%
7/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Investigations
Alanine aminotransferase increased
|
3.4%
3/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
9.3%
8/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
9.0%
8/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
10.5%
9/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Investigations
Weight decreased
|
27.0%
24/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
30.2%
26/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
24.7%
22/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
17.4%
15/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.9%
15/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
22.1%
19/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.4%
11/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
9.3%
8/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
15.7%
14/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
10.5%
9/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.1%
9/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
11.6%
10/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
32.6%
29/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
27.9%
24/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
29.2%
26/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
36.0%
31/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
15.7%
14/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
15.1%
13/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.5%
12/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
7.0%
6/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.2%
10/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
7.0%
6/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.5%
4/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
5.8%
5/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.9%
7/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
7.0%
6/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
3/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
9.3%
8/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Nervous system disorders
Dizziness
|
14.6%
13/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
23.3%
20/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Nervous system disorders
Dysgeusia
|
12.4%
11/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
9.3%
8/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Nervous system disorders
Headache
|
11.2%
10/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
15.1%
13/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
10.1%
9/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
11.6%
10/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Psychiatric disorders
Anxiety
|
6.7%
6/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
8.1%
7/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Psychiatric disorders
Depression
|
9.0%
8/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
7.0%
6/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Psychiatric disorders
Insomnia
|
5.6%
5/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
9.3%
8/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.9%
15/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
18.6%
16/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.4%
3/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
8.1%
7/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.0%
8/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
16.3%
14/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.0%
8/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
4.7%
4/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.6%
5/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
5.8%
5/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.9%
7/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
9.3%
8/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.5%
4/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
7.0%
6/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
48.3%
43/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
36.0%
31/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.2%
10/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
23.3%
20/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
5/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
10.5%
9/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.1%
17/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
26.7%
23/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.1%
9/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
5.8%
5/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
13.5%
12/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
23.3%
20/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Vascular disorders
Hypertension
|
4.5%
4/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
5.8%
5/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
|
Vascular disorders
Hypotension
|
4.5%
4/89 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
17.4%
15/86 • AE data was collected from the first patient's Cycle 1 Day 1, 14 Oct 2013, through primary analysis data cut date, 13 Apr 2016. AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. The whole period equals to 2.5 years.
AEs were collected through reporting voluntarily by the subject, discovery via questioning by the investigator or clinical personnel, or identification through physical examination, laboratory test or other means. Overall mean duration of exposure was 25.3 weeks for study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI should not publish the site's results prior to the sponsor's 1st multi-site publication. PI can publish if no multi-site publication within 18 months after the study has been completed or terminated, provided that the site's results are statistically significant and consistent with the multi-site publication. Prior to submitting or presenting, PI should provide sponsor to review and comment. If requested by sponsor, PI should delay publication/presentation for up to 120 days.
- Publication restrictions are in place
Restriction type: OTHER