Trial Outcomes & Findings for Safety and Efficacy of Combination Listeria/GVAX Immunotherapy in Pancreatic Cancer (NCT NCT01417000)
NCT ID: NCT01417000
Last Updated: 2018-05-08
Results Overview
For all treated subjects, OS was defined as the time between the date of randomization and the date of death or censoring, and was estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs). Subjects without documentation of death at the time of the final analysis were censored using the date the subject was last known to be alive. Per the study protocol, following an Interim Analysis (IA), subjects in the Cy/GVAX arm were offered rollover to Cy/GVAX + CRS-207 arm. 3 subjects rolled over to the Cy/GVAX + CRS-207 arm (rollover subjects). These rollover subjects were censored at the day prior to the first rollover treatment dose date, and were included for analysis in the Cy/GVAX arm. Additionally, 2 subjects originally treated per the Cy/GVAX + CRS-207 arm discontinued treatment and entered follow-up, but following IA were re-treated per the Cy/GVAX + CRS-207 arm regimen. Data from these "re-treated subjects" were included in the Cy/GVAX + CRS-207 arm analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
93 participants
Primary outcome timeframe
Subjects were followed from the date of randomization to the date of death or discontinuation, whichever came first, assessed up to 60 months.
Results posted on
2018-05-08
Participant Flow
This study enrolled subjects with malignant metastatic adenocarcinoma of the pancreas who had received or refused at least one prior chemotherapy regimen. Study was conducted in the United States at 10 medical centers; however, 1 center did not enroll any subjects. The last subject completed the study in February 2017.
Participants screened over a 28-day period.
Participant milestones
| Measure |
Cy/GVAX + CRS-207
200 mg per square meter (mg/m\^2) cyclophosphamide (Cy) administered by intravenous (IV) infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (GVAX, 5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 colony forming units \[CFU\]) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.
|
Cy/GVAX
200 mg/m\^2 Cy administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16; GVAX (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1, 4, 7, 10, 13, 16.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
29
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
61
|
29
|
Reasons for withdrawal
| Measure |
Cy/GVAX + CRS-207
200 mg per square meter (mg/m\^2) cyclophosphamide (Cy) administered by intravenous (IV) infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (GVAX, 5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 colony forming units \[CFU\]) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.
|
Cy/GVAX
200 mg/m\^2 Cy administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16; GVAX (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1, 4, 7, 10, 13, 16.
|
|---|---|---|
|
Overall Study
Death
|
59
|
28
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
1
|
1
|
Baseline Characteristics
Safety and Efficacy of Combination Listeria/GVAX Immunotherapy in Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Cy/GVAX + CRS-207
n=61 Participants
200 mg/m\^2 Cy administered by IV infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.
|
Cy/GVAX
n=29 Participants
200 mg/m\^2 Cy administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1, 4, 7, 10, 13, 16.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 9.14 • n=5 Participants
|
63.9 years
STANDARD_DEVIATION 9.29 • n=7 Participants
|
63.8 years
STANDARD_DEVIATION 9.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Subjects were followed from the date of randomization to the date of death or discontinuation, whichever came first, assessed up to 60 months.Population: Analysis conducted for the FAS of each study arm.
For all treated subjects, OS was defined as the time between the date of randomization and the date of death or censoring, and was estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs). Subjects without documentation of death at the time of the final analysis were censored using the date the subject was last known to be alive. Per the study protocol, following an Interim Analysis (IA), subjects in the Cy/GVAX arm were offered rollover to Cy/GVAX + CRS-207 arm. 3 subjects rolled over to the Cy/GVAX + CRS-207 arm (rollover subjects). These rollover subjects were censored at the day prior to the first rollover treatment dose date, and were included for analysis in the Cy/GVAX arm. Additionally, 2 subjects originally treated per the Cy/GVAX + CRS-207 arm discontinued treatment and entered follow-up, but following IA were re-treated per the Cy/GVAX + CRS-207 arm regimen. Data from these "re-treated subjects" were included in the Cy/GVAX + CRS-207 arm analysis.
Outcome measures
| Measure |
Cy/GVAX + CRS-207
n=61 Participants
200 mg/m\^2 Cy administered by IV infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.
|
Cy/GVAX
n=29 Participants
200 mg/m\^2 Cy administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1, 4, 7, 10, 13, 16.
|
|---|---|---|
|
Overall Survival (OS) in Subjects Receiving Test Treatments (FAS)
|
6.28 months
Interval 4.47 to 9.4
|
4.07 months
Interval 3.32 to 5.42
|
SECONDARY outcome
Timeframe: Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.Population: Analysis conducted for the FAS of each study arm.
Safety was assessed based upon the number of adverse events (AEs) that occurred in the FAS of each treatment arm, including serious AEs and total AEs. Total AEs included both serious and non-serious AEs. AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date.
Outcome measures
| Measure |
Cy/GVAX + CRS-207
n=64 Participants
200 mg/m\^2 Cy administered by IV infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.
|
Cy/GVAX
n=29 Participants
200 mg/m\^2 Cy administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1, 4, 7, 10, 13, 16.
|
|---|---|---|
|
To Assess Safety of the Cyclophosphamide, GVAX Pancreas Vaccine, and CRS-207 Treatment Regimen
Serious AEs
|
29 Participants
|
10 Participants
|
|
To Assess Safety of the Cyclophosphamide, GVAX Pancreas Vaccine, and CRS-207 Treatment Regimen
Total AEs
|
64 Participants
|
29 Participants
|
Adverse Events
Cy/GVAX + CRS-207
Serious events: 29 serious events
Other events: 64 other events
Deaths: 0 deaths
Cy/GVAX
Serious events: 10 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cy/GVAX + CRS-207
n=64 participants at risk
200 mg/m\^2 Cy administered by IV infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.
|
Cy/GVAX
n=29 participants at risk
200 mg/m\^2 Cy administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1, 4, 7, 10, 13, 16.
|
|---|---|---|
|
Gastrointestinal disorders
OBSTRUCTION GASTRIC
|
6.2%
4/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
ASCITES
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
DUODENAL OBSTRUCTION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
NAUSEA
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Hepatobiliary disorders
CHOLANGITIS
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Hepatobiliary disorders
BILE DUCT OBSTRUCTION
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Hepatobiliary disorders
BILE DUCT STENOSIS
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
SEPSIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
10.3%
3/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
BILIARY TRACT INFECTION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
ESCHERICHIA BACTERAEMIA
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
LISTERIOSIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
OSTEOMYELITIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
PERITONITIS BACTERIAL
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Vascular disorders
HYPERTENSION
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Vascular disorders
EMBOLISM
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Vascular disorders
HYPOTENSION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Vascular disorders
NECROSIS ISCHAEMIC
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
DISEASE PROGRESSION
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Metabolism and nutrition disorders
MALNUTRITION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Blood and lymphatic system disorders
DISSEMINATED INTRAVASCULAR COAGULATION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Nervous system disorders
EMBOLIC STROKE
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
SYNOVITIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
Other adverse events
| Measure |
Cy/GVAX + CRS-207
n=64 participants at risk
200 mg/m\^2 Cy administered by IV infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 CFU) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.
|
Cy/GVAX
n=29 participants at risk
200 mg/m\^2 Cy administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16; GVAX pancreas vaccine (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1, 4, 7, 10, 13, 16.
|
|---|---|---|
|
General disorders
VACCINATION SITE ERYTHEMA
|
79.7%
51/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
86.2%
25/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
VACCINATION SITE PRURITUS
|
78.1%
50/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
75.9%
22/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
VACCINATION SITE INDURATION
|
68.8%
44/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
79.3%
23/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
VACCINATION SITE PAIN
|
67.2%
43/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
69.0%
20/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
FATIGUE
|
56.2%
36/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
72.4%
21/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
CHILLS
|
70.3%
45/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
27.6%
8/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
PYREXIA
|
64.1%
41/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
41.4%
12/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
VACCINATION SITE OEDEMA
|
34.4%
22/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
34.5%
10/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
VACCINATION SITE HAEMATOMA
|
25.0%
16/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
31.0%
9/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
VACCINATION SITE REACTION
|
15.6%
10/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
24.1%
7/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
VACCINATION SITE VESICLES
|
17.2%
11/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
20.7%
6/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
PAIN
|
14.1%
9/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
13.8%
4/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
VACCINATION SITE SWELLING
|
10.9%
7/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
17.2%
5/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
ASTHENIA
|
10.9%
7/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
10.3%
3/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
VACCINATION SITE NODULE
|
12.5%
8/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
9.4%
6/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
13.8%
4/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
OEDEMA PERIPHERAL
|
9.4%
6/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
VACCINATION SITE WARMTH
|
7.8%
5/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
13.8%
4/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
VACCINATION SITE HAEMORRHAGE
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
10.3%
3/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
CHEST PAIN
|
6.2%
4/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
EARLY SATIETY
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
6.2%
4/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
OEDEMA
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
VACCINATION SITE DISCOLOURATION
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
VACCINATION SITE RASH
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
APPLICATION SITE VESICLES
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
DISEASE PROGRESSION
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
VACCINATION SITE EXFOLIATION
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
APPLICATION SITE HAEMATOMA
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
APPLICATION SITE PAIN
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
GAIT DISTURBANCE
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
HERNIA
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
INFUSION RELATED REACTION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
INJECTION SITE HAEMATOMA
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
INJECTION SITE NODULE
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
INJECTION SITE PRURITUS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
LOCALISED OEDEMA
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
MALAISE
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
VACCINATION SITE ESCHAR
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
VACCINATION SITE INFLAMMATION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
VACCINATION SITE ULCER
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
General disorders
VENIPUNCTURE SITE THROMBOSIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
NAUSEA
|
56.2%
36/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
37.9%
11/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
VOMITING
|
46.9%
30/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
27.6%
8/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
29.7%
19/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
41.4%
12/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
CONSTIPATION
|
26.6%
17/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
27.6%
8/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
DIARRHOEA
|
23.4%
15/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
24.1%
7/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
ASCITES
|
15.6%
10/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
13.8%
4/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
12.5%
8/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
10.3%
3/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
6.2%
4/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
17.2%
5/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
7.8%
5/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
13.8%
4/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
FLATULENCE
|
7.8%
5/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
10.3%
3/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
DRY MOUTH
|
6.2%
4/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
GASTRITIS
|
6.2%
4/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
OBSTRUCTION GASTRIC
|
6.2%
4/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
FAECAL INCONTINENCE
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
MELAENA
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
DUODENAL ULCER
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
GASTROINTESTINAL SOUNDS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
ABNORMAL INTESTINAL OBSTRUCTION
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
LIP BLISTER
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
STOMATITIS
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
ANAL HAEMORRHAGE
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
ANAL PRURITUS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
COELIAC DISEASE
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
DUODENAL OBSTRUCTION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
DUODENAL STENOSIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
EPIGASTRIC DISCOMFORT
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
EROSIVE OESOPHAGITIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
ERUCTATION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
IMPAIRED GASTRIC EMPTYING
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
OESOPHAGEAL DISORDER
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
RETCHING
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
TONGUE DISORDER
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Gastrointestinal disorders
TOOTHACHE
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
40.6%
26/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
34.5%
10/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
17.2%
11/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
14.1%
9/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
12.5%
8/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
12.5%
8/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
10.9%
7/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
12.5%
8/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
7.8%
5/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
10.9%
7/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Metabolism and nutrition disorders
CACHEXIA
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Metabolism and nutrition disorders
HYPERMAGNESAEMIA
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Metabolism and nutrition disorders
IMPAIRED FASTING GLUCOSE
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Metabolism and nutrition disorders
LACTASE DEFICIENCY
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Metabolism and nutrition disorders
MALNUTRITION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
METABOLIC ACIDOSIS
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
20.3%
13/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
17.2%
5/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
10.9%
7/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
10.3%
3/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
9.4%
6/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
13.8%
4/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
10.3%
3/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
6.2%
4/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
7.8%
5/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
6.2%
4/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
GROIN PAIN
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
NECK MASS
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
AXILLARY MASS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
SYNOVITIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
VERTEBRAL COLUMN MASS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
28.1%
18/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
10.3%
3/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
17.2%
11/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
10.9%
7/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
6.2%
4/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY TRACT CONGESTION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGOSPASM
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
LUNG INFILTRATION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
20.3%
13/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
WEIGHT DECREASED
|
14.1%
9/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
13.8%
4/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
17.2%
11/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
14.1%
9/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
9.4%
6/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
7.8%
5/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
BLOOD CREATININE INCREASED
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
BLOOD ALBUMIN DECREASED
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
BLOOD CREATININE
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
BLOOD SODIUM DECREASED
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
LISTERIA TEST POSITIVE
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
OXYGEN SATURATION DECREASED
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
PLATELET COUNT
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
PLATELET COUNT DECREASED
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
SKIN TURGOR DECREASED
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
TROPONIN I INCREASED
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
URINE OUTPUT DECREASED
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
URINE OUTPUT INCREASED
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
WEIGHT INCREASED
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Investigations
WHITE BLOOD CELL COUNT
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Nervous system disorders
DIZZINESS
|
21.9%
14/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
17.2%
5/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Nervous system disorders
HEADACHE
|
9.4%
6/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
17.2%
5/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Nervous system disorders
SOMNOLENCE
|
14.1%
9/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Nervous system disorders
DYSGEUSIA
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Nervous system disorders
BALANCE DISORDER
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Nervous system disorders
HYPOAESTHESIA
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Nervous system disorders
PARAESTHESIA
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Nervous system disorders
SYNCOPE
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Nervous system disorders
AMNESIA
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Nervous system disorders
ANOSMIA
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Nervous system disorders
COGNITIVE DISORDER
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Nervous system disorders
EMBOLIC STROKE
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Nervous system disorders
ENCEPHALOPATHY
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Nervous system disorders
MENTAL IMPAIRMENT
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Nervous system disorders
NEURALGIA
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Nervous system disorders
SCIATICA
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Nervous system disorders
SINUS HEADACHE
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
28.1%
18/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
27.6%
8/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
10.9%
7/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
6.2%
4/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Blood and lymphatic system disorders
DISSEMINATED INTRAVASCULAR COAGULATION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Blood and lymphatic system disorders
LYMPH NODE PAIN
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Vascular disorders
HYPOTENSION
|
20.3%
13/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Vascular disorders
HYPERTENSION
|
7.8%
5/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
10.3%
3/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Vascular disorders
EMBOLISM
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Vascular disorders
FLUSHING
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Vascular disorders
HOT FLUSH
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Vascular disorders
HAEMATOMA
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Vascular disorders
NECROSIS ISCHAEMIC
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Vascular disorders
VENOUS STENOSIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
6.2%
4/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
10.3%
3/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
RASH
|
9.4%
6/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
7.8%
5/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
SKIN HYPERPIGMENTATION
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
SUBCUTANEOUS NODULE
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
COLD SWEAT
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
HAEMORRHAGE SUBCUTANEOUS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
HYPERKERATOSIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
ONYCHOMADESIS
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
SKIN EXFOLIATION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Psychiatric disorders
INSOMNIA
|
15.6%
10/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Psychiatric disorders
DEPRESSION
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Psychiatric disorders
ANXIETY
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Psychiatric disorders
DELIRIUM
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Psychiatric disorders
HALLUCINATION
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Psychiatric disorders
NIGHTMARE
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Psychiatric disorders
RESTLESSNESS
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Psychiatric disorders
AGITATION
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Psychiatric disorders
DISORIENTATION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Psychiatric disorders
TEARFULNESS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
9.4%
6/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
7.8%
5/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
SEPSIS
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
10.3%
3/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
NASOPHARYNGITIS
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
ORAL HERPES
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
BACTERIAL INFECTION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
BILIARY TRACT INFECTION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
BODY TINEA
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
CANDIDIASIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
CLOSTRIDIAL INFECTION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
ESCHERICHIA BACTERAEMIA
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
HERPES VIRUS INFECTION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
LISTERIOSIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
LUNG INFECTION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
OESOPHAGEAL CANDIDIASIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
ORAL INFECTION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
OSTEOMYELITIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
PENILE INFECTION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
PERITONITIS BACTERIAL
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Infections and infestations
SINUSITIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
7.8%
5/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Renal and urinary disorders
CHROMATURIA
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Renal and urinary disorders
HAEMATURIA
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Renal and urinary disorders
DYSURIA
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Renal and urinary disorders
INCONTINENCE
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Renal and urinary disorders
URINARY RETENTION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Renal and urinary disorders
URINE ODOUR ABNORMAL
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Injury, poisoning and procedural complications
FALL
|
6.2%
4/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Injury, poisoning and procedural complications
EXCORIATION
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Injury, poisoning and procedural complications
AVULSION FRACTURE
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Injury, poisoning and procedural complications
ESCHAR
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Injury, poisoning and procedural complications
GASTROINTESTINAL STOMA COMPLICATION
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Injury, poisoning and procedural complications
JOINT SPRAIN
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Injury, poisoning and procedural complications
PATELLA FRACTURE
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Injury, poisoning and procedural complications
RENAL INJURY
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Injury, poisoning and procedural complications
TOOTH INJURY
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Injury, poisoning and procedural complications
TRANSFUSION REACTION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Cardiac disorders
TACHYCARDIA
|
10.9%
7/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Cardiac disorders
BRADYCARDIA
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Cardiac disorders
CARDIAC DISORDER
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Hepatobiliary disorders
CHOLANGITIS
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
6.9%
2/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Hepatobiliary disorders
BILE DUCT OBSTRUCTION
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Hepatobiliary disorders
BILE DUCT STENOSIS
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
10.3%
3/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Hepatobiliary disorders
JAUNDICE
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Eye disorders
VISION BLURRED
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Eye disorders
BLEPHARITIS
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Eye disorders
CHROMATOPSIA
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Eye disorders
CONJUNCTIVAL DISORDER
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Eye disorders
DRY EYE
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Eye disorders
IRITIS
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Eye disorders
PHOTOPSIA
|
0.00%
0/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
3.4%
1/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Eye disorders
RETINAL TEAR
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Eye disorders
VITREOUS FLOATERS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Ear and labyrinth disorders
EAR DISCOMFORT
|
4.7%
3/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Ear and labyrinth disorders
CERUMEN IMPACTION
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Ear and labyrinth disorders
EAR PAIN
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Ear and labyrinth disorders
TINNITUS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Reproductive system and breast disorders
ATROPHIC VULVOVAGINITIS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Reproductive system and breast disorders
PROSTATIC DISORDER
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Reproductive system and breast disorders
TESTICULAR CYST
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Reproductive system and breast disorders
VAGINAL DISCHARGE
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Reproductive system and breast disorders
VULVOVAGINAL PRURITUS
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
3.1%
2/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Immune system disorders
HYPERSENSITIVITY
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
|
Immune system disorders
SEASONAL ALLERGY
|
1.6%
1/64 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
0.00%
0/29 • Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. AEs reported in the "Other (Not Including Serious) Adverse Events" section include serious and non-serious AEs.
|
Additional Information
Corporate Communications
Aduro Biotech, Inc.
Phone: 510-848-4400
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60