Trial Outcomes & Findings for Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer (NCT NCT02810457)
NCT ID: NCT02810457
Last Updated: 2022-03-10
Results Overview
The primary variable in this study was ORR, defined as the proportion of patients with a BOR of CR or PR (by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)). A BOR was defined as the best response (in the order of CR, PR, stable disease (SD), no evidence of disease (NED), progressive disease (PD), and not evaluable (NE)) among all post-baseline disease assessments that occurred until progression, or last evaluable assessment in the absence of progression prior to the initiation of subsequent anti-cancer therapy, irrespective of whether or not patients discontinued the study treatment. The 95% Pearson-Clopper confidence interval (CI) of ORR for each treatment arm was provided. Per RECIST v1.1 for target lesions and assessed by computed tomography (CT) or, if contraindicated, magnetic resonance imaging (MRI): CR=disappearance of all target lesions; PR=at least 30% decrease from baseline in the sum of diameters of target lesions. Overall Response=CR+PR.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
731 participants
Primary outcome timeframe
Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.
Results posted on
2022-03-10
Participant Flow
Screening occurred at 146 centers in 24 countries (randomized at 136 centers, 24 countries) in Belarus, Bosnia \& Herzegovina, Bulgaria, Croatia, Georgia, Germany, Greece, Hungary, Italy, Japan, South Korea, Peru, Philippines, Poland, Romania, Russia, Serbia, Spain, Taiwan, Thailand, Turkey, Ukraine, US and Vietnam. No screening occurred in Canada.
Of a total of 1023 patients who signed informed consent and were screened, 292 patients were not randomized. Of the 731 randomized patients, 2 patients were randomized in error and never received any study treatment, and 1 patient was randomized but withdrew consent prior to receiving any study treatment.
Participant milestones
| Measure |
FKB238 / Paclitaxel / Carboplatin
Drug: FKB238:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
Area under the curve (AUC) = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
FKB238 (bevacizumab)
Paclitaxel
Carboplatin
|
Avastin / Paclitaxel / Carboplatin
Drug: Avastin:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Avastin (bevacizumab)
Paclitaxel
Carboplatin
|
|---|---|---|
|
Overall Study
STARTED
|
364
|
367
|
|
Overall Study
COMPLETED
|
37
|
38
|
|
Overall Study
NOT COMPLETED
|
327
|
329
|
Reasons for withdrawal
| Measure |
FKB238 / Paclitaxel / Carboplatin
Drug: FKB238:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
Area under the curve (AUC) = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
FKB238 (bevacizumab)
Paclitaxel
Carboplatin
|
Avastin / Paclitaxel / Carboplatin
Drug: Avastin:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Avastin (bevacizumab)
Paclitaxel
Carboplatin
|
|---|---|---|
|
Overall Study
Randomised but no treatment received
|
2
|
1
|
|
Overall Study
Objective PD assessed by RECIST v1.1
|
191
|
199
|
|
Overall Study
Adverse Event
|
37
|
43
|
|
Overall Study
Patient decision
|
31
|
35
|
|
Overall Study
Patient lost to follow-up
|
2
|
2
|
|
Overall Study
Death
|
39
|
28
|
|
Overall Study
Ongoing at data cutoff and discontinued
|
3
|
2
|
|
Overall Study
Clinical progression
|
15
|
16
|
|
Overall Study
Investigator decision
|
3
|
2
|
|
Overall Study
Patient ineligibility
|
3
|
0
|
|
Overall Study
Miscalculated PD
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
FKB238 / Paclitaxel / Carboplatin
n=364 Participants
Drug: FKB238:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
FKB238 (bevacizumab)
Paclitaxel
Carboplatin
|
Avastin / Paclitaxel / Carboplatin
n=367 Participants
Drug: Avastin:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Avastin (bevacizumab)
Paclitaxel
Carboplatin
|
Total
n=731 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Adults (18-64 years)
|
238 Participants
n=99 Participants
|
224 Participants
n=107 Participants
|
462 Participants
n=206 Participants
|
|
Age, Customized
From 65-84 years
|
126 Participants
n=99 Participants
|
143 Participants
n=107 Participants
|
269 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=99 Participants
|
129 Participants
n=107 Participants
|
248 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
245 Participants
n=99 Participants
|
238 Participants
n=107 Participants
|
483 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
316 Participants
n=99 Participants
|
320 Participants
n=107 Participants
|
636 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black and African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian, other than Japanese
|
37 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.Population: In order to meet the Food and Drug Administration (FDA) requirement, the primary efficacy analysis of ORR was performed using the Intent-to-Treat (ITT) population (patients included in each treatment arm as randomized), and the blinded independent central review (BICR) radiological assessments.
The primary variable in this study was ORR, defined as the proportion of patients with a BOR of CR or PR (by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)). A BOR was defined as the best response (in the order of CR, PR, stable disease (SD), no evidence of disease (NED), progressive disease (PD), and not evaluable (NE)) among all post-baseline disease assessments that occurred until progression, or last evaluable assessment in the absence of progression prior to the initiation of subsequent anti-cancer therapy, irrespective of whether or not patients discontinued the study treatment. The 95% Pearson-Clopper confidence interval (CI) of ORR for each treatment arm was provided. Per RECIST v1.1 for target lesions and assessed by computed tomography (CT) or, if contraindicated, magnetic resonance imaging (MRI): CR=disappearance of all target lesions; PR=at least 30% decrease from baseline in the sum of diameters of target lesions. Overall Response=CR+PR.
Outcome measures
| Measure |
FKB238 / Paclitaxel / Carboplatin
n=364 Participants
Drug: FKB238:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
FKB238 (bevacizumab)
Paclitaxel
Carboplatin
|
Avastin / Paclitaxel / Carboplatin
n=367 Participants
Drug: Avastin:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Avastin (bevacizumab)
Paclitaxel
Carboplatin
|
|---|---|---|
|
Overall Response Rate (ORR) Assessed as the Proportion of Patients With a Best Overall Response (BOR) of Either Complete Response (CR) or Partial Response (PR)
|
51.6 percentage of participants
Interval 46.38 to 56.89
|
53.7 percentage of participants
Interval 48.43 to 58.87
|
SECONDARY outcome
Timeframe: From the date of randomization up to Week 19.Population: In order to meet the FDA requirement, the secondary efficacy analysis of ORR was performed using the ITT population (patients included in each treatment arm as randomized), and the BICR radiological assessments.
ORR (by RECIST v1.1) at Week 19 was defined as the proportion of patients with a BOR of CR or PR assessed at Week 19. Only tumor assessments performed up until 19 weeks (i.e. Week 18 assessment + 7 day assessment window) from randomization were considered in this analysis. Per RECIST v1.1 for target lesions and assessed by CT or, if contraindicated, MRI: CR=disappearance of all target lesions; PR=at least 30% decrease from baseline in the sum of diameters of target lesions. Overall Response=CR+PR.
Outcome measures
| Measure |
FKB238 / Paclitaxel / Carboplatin
n=364 Participants
Drug: FKB238:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
FKB238 (bevacizumab)
Paclitaxel
Carboplatin
|
Avastin / Paclitaxel / Carboplatin
n=367 Participants
Drug: Avastin:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Avastin (bevacizumab)
Paclitaxel
Carboplatin
|
|---|---|---|
|
ORR at Week 19
|
47.8 percentage of participants
Interval 42.57 to 53.07
|
51.0 percentage of participants
Interval 45.71 to 56.18
|
SECONDARY outcome
Timeframe: Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.Population: This assessment was performed using the ITT population (patients included in each treatment arm as randomized) and the BICR radiological assessments.
The event of interest for PFS was defined as the interval from the date of randomization until first documented disease progression or death from any cause, whichever occurs first. Disease progression was based on tumor assessments according to RECIST v1.1 criteria. The items of the overall response CR, PR, SD and NED were taken as progression-free whereas PD denoted disease progression. PFS was summarized using Kaplan-Meier estimates of the quartiles for each treatment arm, and 95% CIs for the medians were calculated. Per RECIST v1.1 for target lesions and assessed by CT or, if contraindicated, MRI: PD=at least a 20% increase in the sum of the longest diameter of target lesions, unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.
Outcome measures
| Measure |
FKB238 / Paclitaxel / Carboplatin
n=364 Participants
Drug: FKB238:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
FKB238 (bevacizumab)
Paclitaxel
Carboplatin
|
Avastin / Paclitaxel / Carboplatin
n=367 Participants
Drug: Avastin:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Avastin (bevacizumab)
Paclitaxel
Carboplatin
|
|---|---|---|
|
Progression-free Survival (PFS)
|
7.72 Months
Interval 7.46 to 7.98
|
7.62 Months
Interval 6.9 to 7.82
|
SECONDARY outcome
Timeframe: Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.Population: This assessment was performed using the ITT population (patients included in each treatment arm as randomized).
The event of interest was defined as death from any cause. OS was defined as the interval from date of randomization until the date of death due to any cause. OS was summarized using Kaplan-Meier estimates of the quartiles for each treatment arm, and 95% CIs for the medians were calculated.
Outcome measures
| Measure |
FKB238 / Paclitaxel / Carboplatin
n=364 Participants
Drug: FKB238:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
FKB238 (bevacizumab)
Paclitaxel
Carboplatin
|
Avastin / Paclitaxel / Carboplatin
n=367 Participants
Drug: Avastin:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Avastin (bevacizumab)
Paclitaxel
Carboplatin
|
|---|---|---|
|
Overall Survival (OS)
|
14.13 Months
Interval 12.52 to 16.56
|
16.95 Months
Interval 14.65 to 19.02
|
SECONDARY outcome
Timeframe: Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.Population: This assessment of DOR was based on patients with events in the ITT population (patients included in each treatment arm as randomized), and the BICR radiological assessments.
DOR was evaluated in this study as a secondary efficacy endpoint. Only the patients defined as responders in the primary analysis of ORR were taken into account for the analysis of DOR. The event of interest was defined as first documented disease progression or death due to any reason, whichever occurred first. DOR was defined as the interval from the first documented response (as defined per RECIST v1.1) until the earlier date of the first documented disease progression or death due to any reason. The date of first documented response was taken as the date of the first tumor assessment with an overall visit response of CR or PR. Per RECIST v1.1 for target lesions and assessed by CT or, if contraindicated, MRI: CR=disappearance of all target lesions; PR=at least 30% decrease from baseline in the sum of diameters of target lesions. DOR was calculated in units of months.
Outcome measures
| Measure |
FKB238 / Paclitaxel / Carboplatin
n=188 Participants
Drug: FKB238:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
FKB238 (bevacizumab)
Paclitaxel
Carboplatin
|
Avastin / Paclitaxel / Carboplatin
n=197 Participants
Drug: Avastin:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Avastin (bevacizumab)
Paclitaxel
Carboplatin
|
|---|---|---|
|
Duration Of Response (DOR)
|
6.47 months
Interval 5.39 to 7.69
|
6.31 months
Interval 4.93 to 7.29
|
SECONDARY outcome
Timeframe: Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.Population: This assessment of DCR was based on patients in the ITT population (patients included in each treatment arm as randomized), and the BICR radiological assessments.
The DCR was defined as the proportion of patients defined as responders. The number and percentage of responders and non-responders and the 95% Pearson-Clopper CI of DCR for each treatment arm was provided. The odds ratio for treatment (FKB238 arm versus Avastin arm) and the corresponding 95% Wald CI were produced based on a logistic regression analysis of DCR. Per RECIST v1.1 for target lesions and assessed by CT or, if contraindicated, MRI: CR=disappearance of all target lesions; PR=at least 30% decrease from baseline in the sum of diameters of target lesions; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. DCR=CR+PR+SD (≥ 6 weeks).
Outcome measures
| Measure |
FKB238 / Paclitaxel / Carboplatin
n=364 Participants
Drug: FKB238:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
FKB238 (bevacizumab)
Paclitaxel
Carboplatin
|
Avastin / Paclitaxel / Carboplatin
n=367 Participants
Drug: Avastin:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Avastin (bevacizumab)
Paclitaxel
Carboplatin
|
|---|---|---|
|
Disease Control Rate (DCR) Assessed as the Proportion of Patients With a BOR of Either CR, PR, SD or NED
|
87.6 percentage of participants with response
Interval 83.81 to 90.84
|
87.5 percentage of participants with response
Interval 83.64 to 90.68
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1 Day 1 (pre- and post-infusion), Cycle 2 Day 1 (pre), Cycle 4 Day 1 (pre and post), Cycle 6 Day 1 (pre), discontinuation visit, and every 12 weeks (up to 1 year [±14 days] after randomisation) until death, or the patient was lost to follow-up.Population: All patients randomized to treatment who received at least 1 dose of investigational product with no important protocol deviations, and at least 1 serum drug concentration data after investigational product administration (PK population).
Ctrough (pre-infusion) and serum maximum concentration (Cmax; at completion of infusion) were compared between treatment arms and time points, and descriptive statistics provided. Ctrough and Cmax concentrations were summarized using the pharmacokinetics (PK) population for each visit at which samples were taken. The pre-dose serum concentrations at Cycles 2, 4, and 6 were considered as Ctrough values and the post-dose serum concentrations at Cycles 1 and 4 were considered as Cmax values. PK data at Cycle 1 Day 1 pre-infusion were not calculable and are therefore not presented in the outcome measure data table. Data are only provided for the time points at which the serum trough concentration was measured.
Outcome measures
| Measure |
FKB238 / Paclitaxel / Carboplatin
n=345 Participants
Drug: FKB238:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
FKB238 (bevacizumab)
Paclitaxel
Carboplatin
|
Avastin / Paclitaxel / Carboplatin
n=351 Participants
Drug: Avastin:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Avastin (bevacizumab)
Paclitaxel
Carboplatin
|
|---|---|---|
|
Serum Trough Concentration (Ctrough)
Cycle 2, Day 1 pre-infusion
|
42.74 ug/ml
Geometric Coefficient of Variation 91.9
|
48.48 ug/ml
Geometric Coefficient of Variation 77.3
|
|
Serum Trough Concentration (Ctrough)
Cycle 4, Day 1 pre-infusion
|
77.16 ug/ml
Geometric Coefficient of Variation 69.4
|
83.26 ug/ml
Geometric Coefficient of Variation 85.5
|
|
Serum Trough Concentration (Ctrough)
Cycle 4, Day 1 end of infusion
|
339.91 ug/ml
Geometric Coefficient of Variation 91.3
|
373.92 ug/ml
Geometric Coefficient of Variation 51.6
|
|
Serum Trough Concentration (Ctrough)
Cycle 6, Day 1 pre-infusion
|
87.25 ug/ml
Geometric Coefficient of Variation 124.5
|
108.22 ug/ml
Geometric Coefficient of Variation 69.8
|
|
Serum Trough Concentration (Ctrough)
Cycle 1, Day 1 end of infusion
|
255.15 ug/ml
Geometric Coefficient of Variation 184.3
|
245.11 ug/ml
Geometric Coefficient of Variation 206.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose at Cycles 1, 2, 4 and 6, discontinuation visit, and every 12 weeks (up to 1 year [±14 days] after randomisation) until death, or the patient was lost to follow-up, whichever occurred first.Population: Includes all patients randomized to treatment who received at least 1 dose of investigational product with no important protocol deviations, and who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result (ADA evaluable population).
The ADA levels were summarized at baseline and post-baseline time points using descriptive statistics.
Outcome measures
| Measure |
FKB238 / Paclitaxel / Carboplatin
n=305 Participants
Drug: FKB238:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
FKB238 (bevacizumab)
Paclitaxel
Carboplatin
|
Avastin / Paclitaxel / Carboplatin
n=305 Participants
Drug: Avastin:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Avastin (bevacizumab)
Paclitaxel
Carboplatin
|
|---|---|---|
|
Proportion of Patients Developing Anti-drug Antibodies (ADAs)
ADA prevalence (ADA positive, baseline or post)
|
3.0 percentage of participants
|
3.0 percentage of participants
|
|
Proportion of Patients Developing Anti-drug Antibodies (ADAs)
Treatment-emergent ADA positive (ADA incidence)
|
2.3 percentage of participants
|
2.3 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months.Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to approximately 30 days after last dose of study treatment.Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to approximately 30 days after last dose of study treatment.Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to approximately 30 days after last dose of study treatment.Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to approximately 30 days after last dose of study treatment.Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to approximately 30 days after last dose of study treatment.Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to approximately 30 days after last dose of study treatment.Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to approximately 30 days after last dose of study treatment.Outcome measures
Outcome data not reported
Adverse Events
FKB238 / Paclitaxel / Carboplatin
Serious events: 91 serious events
Other events: 341 other events
Deaths: 195 deaths
Avastin / Paclitaxel / Carboplatin
Serious events: 95 serious events
Other events: 348 other events
Deaths: 177 deaths
Serious adverse events
| Measure |
FKB238 / Paclitaxel / Carboplatin
n=362 participants at risk
Drug: FKB238:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
FKB238 (bevacizumab)
Paclitaxel
Carboplatin
|
Avastin / Paclitaxel / Carboplatin
n=366 participants at risk
Drug: Avastin:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Avastin (bevacizumab)
Paclitaxel
Carboplatin
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
5/362 • Number of events 5 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
2.5%
9/366 • Number of events 10 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.9%
7/362 • Number of events 7 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
1.4%
5/366 • Number of events 5 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.9%
7/362 • Number of events 8 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
4.9%
18/366 • Number of events 19 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.55%
2/366 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.55%
2/362 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.55%
2/366 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.83%
3/362 • Number of events 3 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.55%
2/362 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Cardiac disorders
Cor pulmonale
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Cardiac disorders
Myocardial infarction
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.82%
3/366 • Number of events 3 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Gastrointestinal disorders
Haematemesis
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Gastrointestinal disorders
Ileal perforation
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Gastrointestinal disorders
Vomiting
|
0.83%
3/362 • Number of events 3 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.55%
2/366 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
General disorders
Asthenia
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
General disorders
Death
|
1.4%
5/362 • Number of events 5 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.82%
3/366 • Number of events 3 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
General disorders
Fatigue
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
General disorders
General physical health deterioration
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.55%
2/366 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
General disorders
Oedema peripheral
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
General disorders
Pyrexia
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
General disorders
Sudden death
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.55%
2/366 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Immune system disorders
Hypersensitivity
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.55%
2/366 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Infections and infestations
Empyema
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Infections and infestations
Lung infection
|
0.55%
2/362 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Infections and infestations
Peritonitis
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Infections and infestations
Pneumonia
|
2.8%
10/362 • Number of events 12 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
2.5%
9/366 • Number of events 10 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Infections and infestations
Sepsis
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.55%
2/366 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Infections and infestations
Septic shock
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Investigations
Neutrophil count decreased
|
0.83%
3/362 • Number of events 4 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.55%
2/366 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Investigations
Platelet count decreased
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Investigations
White blood cell count decreased
|
0.55%
2/362 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.55%
2/366 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.55%
2/366 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Nervous system disorders
Cerebral atrophy
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.55%
2/362 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.82%
3/366 • Number of events 3 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Nervous system disorders
Epilepsy
|
0.55%
2/362 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Nervous system disorders
Facial paresis
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Nervous system disorders
Polyneuropathy
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Nervous system disorders
Presyncope
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Nervous system disorders
Seizure
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Nervous system disorders
Uraemic encephalopathy
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.55%
2/366 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.55%
2/362 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.55%
2/362 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.82%
3/366 • Number of events 3 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.55%
2/362 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Respiratory, thoracic and mediastinal disorders
Oesophagobronchial fistula
|
0.55%
2/362 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.28%
1/362 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.55%
2/362 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
1.1%
4/366 • Number of events 4 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
6/362 • Number of events 6 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
1.4%
5/366 • Number of events 5 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.83%
3/362 • Number of events 4 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.55%
2/362 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.00%
0/366 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.28%
1/362 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.82%
3/366 • Number of events 3 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Vascular disorders
Hypertension
|
0.55%
2/362 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.27%
1/366 • Number of events 1 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/362 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
0.55%
2/366 • Number of events 2 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
Other adverse events
| Measure |
FKB238 / Paclitaxel / Carboplatin
n=362 participants at risk
Drug: FKB238:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
FKB238 (bevacizumab)
Paclitaxel
Carboplatin
|
Avastin / Paclitaxel / Carboplatin
n=366 participants at risk
Drug: Avastin:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Avastin (bevacizumab)
Paclitaxel
Carboplatin
|
|---|---|---|
|
Vascular disorders
Hypertension
|
11.6%
42/362 • Number of events 47 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
12.0%
44/366 • Number of events 54 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Investigations
Alanine aminotransferase increased
|
10.5%
38/362 • Number of events 53 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
9.6%
35/366 • Number of events 45 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Investigations
Aspartate aminotransferase
|
8.8%
32/362 • Number of events 43 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
9.6%
35/366 • Number of events 45 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.2%
19/362 • Number of events 24 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
7.4%
27/366 • Number of events 39 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Investigations
Gamma-glutamyltransferase
|
10.5%
38/362 • Number of events 48 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
8.5%
31/366 • Number of events 46 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Investigations
Neutrophil count decreased
|
6.6%
24/362 • Number of events 32 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
6.8%
25/366 • Number of events 30 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Investigations
Platelet count decreased
|
8.3%
30/362 • Number of events 48 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
6.8%
25/366 • Number of events 38 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Investigations
Weight decreased
|
11.3%
41/362 • Number of events 48 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
15.3%
56/366 • Number of events 62 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Investigations
White blood cell count decreased
|
6.6%
24/362 • Number of events 36 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
7.1%
26/366 • Number of events 36 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.7%
17/362 • Number of events 20 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
6.8%
25/366 • Number of events 26 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.7%
17/362 • Number of events 17 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
7.9%
29/366 • Number of events 29 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.4%
16/362 • Number of events 20 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
6.3%
23/366 • Number of events 36 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Blood and lymphatic system disorders
Anaemia
|
29.0%
105/362 • Number of events 135 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
32.5%
119/366 • Number of events 146 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.9%
43/362 • Number of events 58 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
13.7%
50/366 • Number of events 89 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Blood and lymphatic system disorders
Neutropenia
|
30.1%
109/362 • Number of events 163 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
39.6%
145/366 • Number of events 212 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.2%
44/362 • Number of events 78 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
18.0%
66/366 • Number of events 102 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Nervous system disorders
Headache
|
5.0%
18/362 • Number of events 21 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
6.3%
23/366 • Number of events 24 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Nervous system disorders
Neuropathy peripheral
|
16.0%
58/362 • Number of events 63 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
14.2%
52/366 • Number of events 60 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Nervous system disorders
Paraesthesia
|
6.6%
24/362 • Number of events 26 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
6.0%
22/366 • Number of events 22 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.7%
28/362 • Number of events 28 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
6.8%
25/366 • Number of events 25 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Nervous system disorders
Polyneuropathy
|
4.4%
16/362 • Number of events 18 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
6.3%
23/366 • Number of events 31 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
General disorders
Asthenia
|
10.2%
37/362 • Number of events 45 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
16.1%
59/366 • Number of events 71 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
General disorders
Fatigue
|
11.3%
41/362 • Number of events 55 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
12.3%
45/366 • Number of events 48 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
General disorders
Non-cardiac chest pain
|
5.0%
18/362 • Number of events 18 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
3.0%
11/366 • Number of events 15 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
General disorders
Pyrexia
|
4.1%
15/362 • Number of events 17 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
5.7%
21/366 • Number of events 24 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Gastrointestinal disorders
Constipation
|
5.2%
19/362 • Number of events 23 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
5.7%
21/366 • Number of events 23 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.7%
35/362 • Number of events 44 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
9.6%
35/366 • Number of events 41 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Gastrointestinal disorders
Nausea
|
14.4%
52/362 • Number of events 72 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
12.3%
45/366 • Number of events 57 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Gastrointestinal disorders
Vomiting
|
6.6%
24/362 • Number of events 29 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
4.9%
18/366 • Number of events 24 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Renal and urinary disorders
Proteinuria
|
6.6%
24/362 • Number of events 31 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
11.2%
41/366 • Number of events 52 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
42.5%
154/362 • Number of events 157 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
43.4%
159/366 • Number of events 162 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.8%
32/362 • Number of events 49 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
9.8%
36/366 • Number of events 48 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
22/362 • Number of events 25 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
3.8%
14/366 • Number of events 14 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.0%
29/362 • Number of events 61 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
8.7%
32/366 • Number of events 73 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.9%
43/362 • Number of events 56 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
11.5%
42/366 • Number of events 48 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.9%
14/362 • Number of events 18 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
6.0%
22/366 • Number of events 29 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
|
Infections and infestations
Pneumonia
|
5.0%
18/362 • Number of events 20 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
|
5.5%
20/366 • Number of events 24 • From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months. All ongoing and any new AEs/serious AEs (SAEs) identified during the 30 days after last dose were followed to resolution unless the event was considered by the investigator to be unlikely to resolve, or if the patient was lost to follow-up.
All safety summaries and analyses were based on the Safety Population. Adverse events (AEs) were coded using the latest Medical Dictionary for Regulatory Activities(MedDRA) version (21.1). AEs were categorized as treatment-emergent AEs. Intensity of AEs was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 grading system.
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Additional Information
Clinical Trial Information
Centus Biotherapeutics Limited
Phone: +353 1 609 7100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publications/presentations made within 2 years of study completion require the Sponsor or CRO's prior written consent. The Sponsor shall be provided with copies of any materials relating to the study that they intend to publish/present at least 30 days in advance of publication, submission or presentation and the Institution shall withhold publication, submission or presentation for 90 days from the date on which the Sponsor receives the material (total time-frame of 120 days).
- Publication restrictions are in place
Restriction type: OTHER