Trial Outcomes & Findings for An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer (NCT NCT00738699)
NCT ID: NCT00738699
Last Updated: 2017-03-30
Results Overview
PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression as determined by modified Response Evaluation Criteria in Solid Tumors (RECIST), or death regardless of cause. If progression or death was not observed, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
415 participants
Primary outcome timeframe
Date of Randomization to date of disease progression or death (whichever came first), assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months
Results posted on
2017-03-30
Participant Flow
Participant milestones
| Measure |
MORAb-003 (Farletuzumab) Plus Paclitaxel
Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m\^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
|
Placebo (Normal Saline) Plus Paclitaxel
An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m\^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
|
|---|---|---|
|
Overall Study
STARTED
|
275
|
140
|
|
Overall Study
Participants Not Treated
|
2
|
1
|
|
Overall Study
Participants Treated
|
273
|
139
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
275
|
140
|
Reasons for withdrawal
| Measure |
MORAb-003 (Farletuzumab) Plus Paclitaxel
Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m\^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
|
Placebo (Normal Saline) Plus Paclitaxel
An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m\^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Death
|
144
|
68
|
|
Overall Study
Discontinuation of study by Sponsor
|
123
|
72
|
|
Overall Study
Other
|
2
|
0
|
Baseline Characteristics
An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer
Baseline characteristics by cohort
| Measure |
MORAb-003 (Farletuzumab) Plus Paclitaxel
n=275 Participants
Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m\^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
|
Placebo (Normal Saline) Plus Paclitaxel
n=140 Participants
An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m\^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
|
Total
n=415 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.9 Years
STANDARD_DEVIATION 10.74 • n=99 Participants
|
61.2 Years
STANDARD_DEVIATION 9.44 • n=107 Participants
|
61.0 Years
STANDARD_DEVIATION 10.31 • n=206 Participants
|
|
Sex: Female, Male
Female
|
275 Participants
n=99 Participants
|
140 Participants
n=107 Participants
|
415 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Date of Randomization to date of disease progression or death (whichever came first), assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 monthsPopulation: Intent-To-Treat (ITT) population included all participants who were randomly assigned to study drug, analyzed by treatment assignment.
PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression as determined by modified Response Evaluation Criteria in Solid Tumors (RECIST), or death regardless of cause. If progression or death was not observed, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier).
Outcome measures
| Measure |
MORAb-003 (Farletuzumab) Plus Paclitaxel
n=275 Participants
Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m\^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
|
Placebo (Normal Saline) Plus Paclitaxel
n=140 Participants
An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m\^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
3.5 Months
Interval 3.3 to 3.9
|
3.7 Months
Interval 3.3 to 5.2
|
PRIMARY outcome
Timeframe: Date of Randomization to date of death, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 monthsPopulation: ITT population included all participants who were randomly assigned to study drug and analyzed by the treatment assigned.
OS was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier.
Outcome measures
| Measure |
MORAb-003 (Farletuzumab) Plus Paclitaxel
n=275 Participants
Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m\^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
|
Placebo (Normal Saline) Plus Paclitaxel
n=140 Participants
An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m\^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
|
|---|---|---|
|
Overall Survival (OS)
|
11.3 Months
Interval 10.3 to 12.7
|
13.1 Months
Interval 10.3 to 16.7
|
SECONDARY outcome
Timeframe: Date of first study drug to disease progression/recurrence, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 monthsPopulation: ITT population included all participants who were randomly assigned to study drug and analyzed by the treatment assigned.
BOR was defined as the percentage of participants having either a confirmed complete response (CR) or confirmed partial response (PR) using modified RECIST criteria by independent radiologist review. RECIST criteria was adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Tumor assessments performed up to the initiation of further antitumor treatment were considered. Target lesions selected for response assessment were measured using computed tomography (CT) or magnetic resonance imaging (MRI) scans then graded according to the modified RECIST criteria, adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Participants were assigned to one of the categories of change in disease state; CR, PR, progressive disease (PD), stable disease ( S)D, or not evaluable (NE).
Outcome measures
| Measure |
MORAb-003 (Farletuzumab) Plus Paclitaxel
n=275 Participants
Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m\^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
|
Placebo (Normal Saline) Plus Paclitaxel
n=140 Participants
An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m\^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
|
|---|---|---|
|
Best Overall Response
Complete response (CR)
|
0.4 Percentage of participants
|
0 Percentage of participants
|
|
Best Overall Response
Partial response (PR)
|
7.3 Percentage of participants
|
15.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Date of Randomization to the first documentation of objective TR, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 monthsPopulation: ITT population (Responders only) included all participants who were randomly assigned to study drug and analyzed by the treatment assigned.
TTR was derived for those participants with objective evidence of CR or PR, and was defined as the time (in months) from the date of randomization to the first documentation of object tumor response (TR). Analysis was based on the Kaplan-Meier estimated percentage of responders. This statistical analysis method measures the effect of study drug on tumor response over a period of time.
Outcome measures
| Measure |
MORAb-003 (Farletuzumab) Plus Paclitaxel
n=21 Participants
Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m\^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
|
Placebo (Normal Saline) Plus Paclitaxel
n=21 Participants
An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m\^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
|
|---|---|---|
|
Time to Tumor Response (TTR)
|
2.0 Months
Interval 1.6 to 3.5
|
1.7 Months
Interval 1.6 to 3.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Length of studyPopulation: Due to termination of the study, data were not collected and the outcome measure for PFS based on GCIG was not analyzed.
Due to termination of the study, data were not collected and the outcome measure for PFS based on GCIG was not analyzed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Length of studyPopulation: Due to termination of the study, data were not collected and the outcome measure for Serologic Response Rate was not analyzed.
Due to termination of the study, data were not collected and the outcome measure for Serologic Response Rate was not analyzed.
Outcome measures
Outcome data not reported
Adverse Events
MORAb-003 (Farletuzumab) Plus Paclitaxel
Serious events: 127 serious events
Other events: 278 other events
Deaths: 0 deaths
Placebo (Normal Saline) Plus Paclitaxel
Serious events: 55 serious events
Other events: 133 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MORAb-003 (Farletuzumab) Plus Paclitaxel
n=279 participants at risk
Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m\^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
|
Placebo (Normal Saline) Plus Paclitaxel
n=133 participants at risk
An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m\^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.5%
7/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
5.3%
7/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.2%
6/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
1.4%
4/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.72%
2/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.72%
2/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
6.5%
18/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
5.3%
7/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
3.6%
10/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
3.0%
4/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
9/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
3.8%
5/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Constipation
|
3.2%
9/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
1.5%
2/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Ascites
|
2.9%
8/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
1.5%
2/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Nausea
|
1.8%
5/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
2.3%
3/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.8%
5/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.72%
2/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
2.3%
3/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Colonic Obstruction
|
1.1%
3/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Ileus
|
0.72%
2/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.72%
2/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Gastrointestinal Obstruction
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.72%
2/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Large Intestinal Obstruction
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Colonic Pseudo-obstruction
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Diverticulum
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Enterocutaneous Fistula
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Faecal Volume Decreased
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Faecal Volume Increased
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Gastrointestinal Inflammation
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Gastrointestinal Perforation
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Oesophageal Obstruction
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Rectourethral Fistula
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Short-Bowel Syndrome
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
General disorders
Disease Progression
|
6.1%
17/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
5.3%
7/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
General disorders
Pyrexia
|
5.4%
15/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
1.5%
2/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
General disorders
Fatigue
|
1.1%
3/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
General disorders
Asthenia
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
General disorders
Obstruction
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
General disorders
Pain
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
General disorders
Generalised Oedema
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
General disorders
Hernia Obstructive
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
General disorders
Oedema Peripheral
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Hepatobiliary disorders
Cholangitis
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Cellulitis
|
2.2%
6/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
1.5%
2/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Urinary Tract Infection
|
1.8%
5/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
2.3%
3/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Pneumonia
|
1.4%
4/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
1.5%
2/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Sepsis
|
1.1%
3/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Catheter Site Infection
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Device Related Infection
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Infection
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Lobar Pneumonia
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Abdominal Infection
|
0.00%
0/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Bacterial Pyelonephritis
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Candida Sepsis
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Clostridium Difficle Colitis
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Escherichia Sepsis
|
0.00%
0/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Herpes Zoster
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Incision Site Infection
|
0.00%
0/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Infectious Peritonitis
|
0.00%
0/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Klebsiella Bacteraemia
|
0.00%
0/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Meningitis
|
0.00%
0/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Parotitis
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Pelvic Infection
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Postoperative Wound Infection
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Pseudomonal Sepsis
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Retroperitoneal Abcess
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Urosepsis
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Injury, poisoning and procedural complications
Postoperative Ileus
|
0.00%
0/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Investigations
Weight decreased
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
4/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.72%
2/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle Necrosis
|
0.00%
0/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Musculoskeletal and connective tissue disorders
Systemic Lupus Erythematosus
|
0.00%
0/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncologic Complication
|
1.1%
3/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Central Nervous System
|
0.00%
0/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
1.5%
2/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Neoplasm
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Associated Fever
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Nervous system disorders
Syncope
|
0.72%
2/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Nervous system disorders
Brain Mass
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Nervous system disorders
Convulsion
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Nervous system disorders
Encephelopathy
|
0.00%
0/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Nervous system disorders
Lethargy
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Nervous system disorders
Mononeuritis
|
0.00%
0/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Nervous system disorders
Posterior Reversible Encephelopathy Syndrome
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Psychiatric disorders
Depression
|
0.72%
2/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Psychiatric disorders
Anxiety
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Psychiatric disorders
Disorientation
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Psychiatric disorders
Mental Status Change
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.72%
2/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
1.5%
2/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.72%
2/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Renal and urinary disorders
Renal Failure
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
1.5%
2/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Renal and urinary disorders
Bladder Spasm
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Renal and urinary disorders
Dysuria
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Renal and urinary disorders
Ureteric Obstruction
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
3.6%
10/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
3.0%
4/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.5%
7/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
3.0%
4/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.1%
3/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
1.5%
2/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.8%
5/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Skin and subcutaneous tissue disorders
Dermatits Exfoliative
|
0.00%
0/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Skin and subcutaneous tissue disorders
Skin Toxicity
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Vascular disorders
Hypotension
|
0.72%
2/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
1.5%
2/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Vascular disorders
Thrombosis
|
1.1%
3/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Vascular disorders
Subclavian Vein Thrombosis
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Vascular disorders
Superior Vena Cava Syndrome
|
0.00%
0/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Vascular disorders
Venous Thrombosis Limb
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Pneumonia bacterial
|
0.36%
1/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.00%
0/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
Other adverse events
| Measure |
MORAb-003 (Farletuzumab) Plus Paclitaxel
n=279 participants at risk
Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m\^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
|
Placebo (Normal Saline) Plus Paclitaxel
n=133 participants at risk
An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m\^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
47.3%
132/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
49.6%
66/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
42.7%
119/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
39.8%
53/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Constipation
|
34.4%
96/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
39.8%
53/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
31.5%
88/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
25.6%
34/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Vomiting
|
30.1%
84/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
27.8%
37/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Abdominal Distension
|
18.3%
51/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
15.8%
21/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Ascites
|
7.9%
22/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
8.3%
11/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Stomatitis
|
9.3%
26/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
5.3%
7/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.9%
22/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
7.5%
10/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
9.0%
25/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
4.5%
6/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Dry mouth
|
6.8%
19/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
6.0%
8/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Small intestinal Obstruction
|
6.8%
19/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
5.3%
7/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Flatulence
|
6.5%
18/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
3.8%
5/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Gastrointestinal disorders
Gastroresophageal Reflux Disease
|
3.6%
10/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
6.0%
8/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
General disorders
Fatigue
|
65.9%
184/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
61.7%
82/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
General disorders
Oedema Peripheral
|
21.5%
60/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
19.5%
26/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
General disorders
Pyrexia
|
15.4%
43/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
13.5%
18/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
General disorders
Asthenia
|
8.6%
24/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
9.0%
12/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
General disorders
Mucosal Inflammation
|
8.6%
24/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
8.3%
11/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
General disorders
Chills
|
6.5%
18/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
5.3%
7/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
General disorders
Disease Progression
|
6.1%
17/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
5.3%
7/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
General disorders
Pain
|
6.1%
17/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
5.3%
7/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
General disorders
Oedema
|
2.2%
6/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
5.3%
7/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Nervous system disorders
Neuropathy Peripheral
|
26.9%
75/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
27.8%
37/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Nervous system disorders
Headache
|
25.8%
72/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
21.1%
28/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Nervous system disorders
Dizziness
|
15.1%
42/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
13.5%
18/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
13.6%
38/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
11.3%
15/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Nervous system disorders
Dysguesia
|
10.4%
29/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
16.5%
22/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Nervous system disorders
Restless Legs Syndrome
|
5.0%
14/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
1.5%
2/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Nervous system disorders
Hypoaesthesia
|
2.2%
6/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
5.3%
7/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.8%
58/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
20.3%
27/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.1%
56/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
15.8%
21/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
17.9%
50/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
18.8%
25/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
10.4%
29/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
4.5%
6/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
5.7%
16/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
9.8%
13/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
3.2%
9/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
6.8%
9/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Urinary Tract Infection
|
16.8%
47/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
22.6%
30/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.6%
24/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
4.5%
6/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Nasopharyngitits
|
5.7%
16/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
3.0%
4/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Infections and infestations
Sinusitis
|
3.6%
10/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
6.8%
9/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.4%
43/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
16.5%
22/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.9%
36/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
19.5%
26/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
28/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
12.8%
17/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
11.1%
31/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
9.0%
12/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
5.0%
14/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
9.0%
12/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
5.4%
15/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
4.5%
6/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
5.0%
14/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
4.5%
6/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
24.0%
67/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
20.3%
27/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
11.1%
31/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
13.5%
18/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
28/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
6.8%
9/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
14/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
3.8%
5/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Blood and lymphatic system disorders
Anaemia
|
28.0%
78/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
27.8%
37/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.6%
38/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
13.5%
18/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.7%
16/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
6.8%
9/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Psychiatric disorders
Insomnia
|
19.4%
54/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
17.3%
23/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Psychiatric disorders
Anxiety
|
9.0%
25/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
12.0%
16/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Psychiatric disorders
Depression
|
8.6%
24/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
6.0%
8/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Vascular disorders
Flushing
|
10.0%
28/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
6.8%
9/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Vascular disorders
Hypotension
|
3.6%
10/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
5.3%
7/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Renal and urinary disorders
Dysuria
|
3.2%
9/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
9.0%
12/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Renal and urinary disorders
Pollakiuria
|
2.5%
7/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
6.8%
9/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.8%
19/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
0.75%
1/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Eye disorders
Vision Blurred
|
5.0%
14/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
6.0%
8/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
51.3%
143/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
44.4%
59/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.7%
55/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
14.3%
19/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
16.8%
47/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
14.3%
19/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.5%
18/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
5.3%
7/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.5%
18/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
4.5%
6/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.4%
15/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
6.0%
8/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.7%
13/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
5.3%
7/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
3.9%
11/279 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
5.3%
7/133 • From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
|
Additional Information
Eisai Medical Services
Eisai Inc.
Phone: 1-888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER