A Randomized, Double-blind, Phase 3 Efficacy Trial of PRO... | NCT01322490

NCT01322490

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PROSTVAC-V/F-TRICOM + GM-CSF	Experimental	PROSTVAC-V-TRICOM PROSTVAC-F-TRICOM GM-CSF	Biological: PROSTVAC-V Biological: PROSTVAC-F Drug: GM-CSF
PROSTVAC-V/F-TRICOM + GM-CSF placebo	Experimental	PROSTVAC-V-TRICOM PROSTVAC-F-TRICOM GM-CSF placebo	Biological: PROSTVAC-V Biological: PROSTVAC-F Other: GM-CSF Placebo
Placebo Control	Placebo Comparator	PROSTVAC V/F Placebo + GM-CSF Placebo	Other: GM-CSF Placebo Biological: Placebo

Name	Type	Description	Arm Group Labels	Other Names
PROSTVAC-V	Biological		PROSTVAC-V/F-TRICOM + GM-CSF PROSTVAC-V/F-TRICOM + GM-CSF placebo
PROSTVAC-F

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival	The time between the date of randomization and the date of death due to any cause. Subjects who did not experience death or the competing events of "definite" loss to follow-up or withdrawal of consent were right censored at the date of last contact. OS was calculated using the formula: OS = Date of death/competing event/censoring - date of randomization + 1.	Randomization through the date of death due to any cause. Subjects were followed up for approximately 6 years from the first subject randomized to the completion of the study.

Secondary Outcomes

Measure	Description	Time Frame
Number of Subjects Alive Without Event at 6 Months	A binary assessment that was performed for the 6-months timepoint for the categories of radiographic progression, pain progression, initiation of chemotherapy or death. Subjects without an event prior to 6-months were evaluated at 6-months. Subjects without event by 6-months and were not evaluated at 6-months were assumed to have had an event and analyzed as such. Progression events were defined as: (1) Two new lesions on bone scan, new metastases on CT scans, or an increased size of nodal lesions per RECIST 1.1. Bone or CT scans occurring prior to calendar month 6 were used to determine radiographic progression. (2) Introduction of scheduled opioid narcotics for cancer-related pain control. (3) Initiation of chemotherapy for prostate cancer was assessed as collected on progression forms as well as in cancer treatment and concomitant medications logs. (4) Death.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men, ≥18years of age with documented asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.

Documented progressive disease post surgical castration or during androgen suppression therapy, or during complete androgen blockade therapy and withdrawal. Documented by either criterion a (Radiological progression), OR criterion b (PSA progression).

Radiological progression defined as any new/enlarging bone metastases or new/enlarging lymph node disease, consistent with prostate cancer.

OR
PSA progression defined by sequence of rising values separated by > 1 week (2 separate increasing values) over a threshold minimum of 2.0 ng/ml. (PCWG2 PSA eligibility criteria).

Chemotherapy naïve and Vaccinia-experienced (previous smallpox vaccination). Currently using a GnRH agonist or antagonist (unless surgically castrated).

Exclusion Criteria:

Cancer-related pain requiring scheduled opioid narcotics for control (as needed, ≤ 2x per week is allowed).

Metastasis to organ systems other than lymph nodes and/or bone. Estimated PSA doubling time of <1 month as established within 6 months of the anticipated first dose of vaccine or placebo.

Concurrent or prior Provenge (sipuleucel-T) immunotherapy for prostate cancer. Receipt of an investigational agent within 30 days (or 60 days for an antibody-based therapy) of the first planned dose of PROSTVAC-V/F.

History of prior malignancies other than prostate cancer within the past 3 years, excluding successfully resected basal or squamous cell carcinoma of the skin.

Congestive heart failure (NYHA Class II, III, or IV), unstable angina, ventricular or hemodynamically significant atrial arrhythmia, or cardiovascular disease such as stroke or myocardial infarction (current or within the past 6 months) Confirmed positive for HIV, hepatitis B, and /or hepatitis C. Immunodeficiency or splenectomy. History of or active autoimmune disease, persons with vitiligo are not excluded. Diabetics are not excluded if the condition is well controlled.

History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis.

Contacts/Locations Module

Name	Affiliation	Role
James L. Gulley, MD	National Cancer Institute (NCI)	Principal Investigator
Philip Kantoff, MD	Dana-Farber Cancer Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Alaska Clinical Research Center, Llc		Anchorage	Alaska	99508	United States
Scottsdale Healthcare

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30817251	Derived	Gulley JL, Borre M, Vogelzang NJ, Ng S, Agarwal N, Parker CC, Pook DW, Rathenborg P, Flaig TW, Carles J, Saad F, Shore ND, Chen L, Heery CR, Gerritsen WR, Priou F, Langkilde NC, Novikov A, Kantoff PW. Phase III Trial of PROSTVAC in Asymptomatic or Minimally Symptomatic Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2019 May 1;37(13):1051-1061. doi: 10.1200/JCO.18.02031. Epub 2019 Feb 28.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	PROSTVAC-V/F-TRICOM + GM-CSF Placebo	PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Jun 29, 2015	Jul 5, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Intent to treat, including all randomized subjects.

Arm/Group Information

ID	Title	Description
BG000	PROSTVAC-V/F-TRICOM + GM-CSF Placebo	PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).
BG001	PROSTVAC-V/F-TRICOM + GM-CSF	PROSTVAC V/F + GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). GM-CSF is given SC at 100ug (on days of PROSTVAC injection and three subsequent days).
BG002	Placebo Control	Placebo PROSTVAC V/F + Placebo GM-CSF, where Placebo PROSTVAC V/F is an empty fowlpox vector (Day 1, Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00071.3± 8.00 BG00170.6± 8.42 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0000 BG0010 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00011 BG00111 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Puerto Rico

Title	Measurements
	BG0002 BG0011 BG002

Randomization Stratum

Randomization stratum based on PSA 50ng/mL cut and LDH 200 U/L cut at baseline.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
PSA < 50 ng/mL and LDH < 200 U/L	BG000168 BG001168 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Overall Survival

The time between the date of randomization and the date of death due to any cause. Subjects who did not experience death or the competing events of "definite" loss to follow-up or withdrawal of consent were right censored at the date of last contact. OS was calculated using the formula: OS = Date of death/competing event/censoring - date of randomization + 1.

Intent to treat, including all randomized subjects.

Posted

Median

95% Confidence Interval

Months

Randomization through the date of death due to any cause. Subjects were followed up for approximately 6 years from the first subject randomized to the completion of the study.

ID	Title	Description
OG000	PROSTVAC-V/F-TRICOM + GM-CSF Placebo	PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).
OG001	PROSTVAC-V/F-TRICOM + GM-CSF	PROSTVAC V/F + GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). GM-CSF is given SC at 100ug (on days of PROSTVAC injection and three subsequent days).
OG002	Placebo Control	Placebo PROSTVAC V/F + Placebo GM-CSF, where Placebo PROSTVAC V/F is an empty fowlpox vector (Day 1, Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).

Units	Counts
Participants	OG000432 OG001432 OG002433

Title

Denominators

Categories

Title	Measurements
	OG00034.4(31.0 to 36.9) OG00133.2(30.6 to 37.4) OG00234.3(30.7 to 37.0)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Log Rank	The primary analysis method was a stratified log-rank test, and was performed using the ITT Set analyzing data according to the randomized arm.	0.4742	The overall type-one error probability for the entire trial was designed as a one-sided P=0.025. There were two main overall comparisons, which necessitated a type-one error probability to 0.0125 for each comparison using a Bonferroni correction.													Superiority	One-sided p-value is from a stratified log-rank test for PROSTVAC-V/F-TRICOM + GM-CSF placebo vs. Placebo Control with Treatment Arm included in model. Stratification is by randomization strata.

Secondary

Number of Subjects Alive Without Event at 6 Months

A binary assessment that was performed for the 6-months timepoint for the categories of radiographic progression, pain progression, initiation of chemotherapy or death. Subjects without an event prior to 6-months were evaluated at 6-months. Subjects without event by 6-months and were not evaluated at 6-months were assumed to have had an event and analyzed as such.

Progression events were defined as: (1) Two new lesions on bone scan, new metastases on CT scans, or an increased size of nodal lesions per RECIST 1.1. Bone or CT scans occurring prior to calendar month 6 were used to determine radiographic progression. (2) Introduction of scheduled opioid narcotics for cancer-related pain control. (3) Initiation of chemotherapy for prostate cancer was assessed as collected on progression forms as well as in cancer treatment and concomitant medications logs. (4) Death.

Intent to treat, including all randomized subjects.

Posted

Count of Participants

Participants

Randomization through Week 25/End of Treatment visit.

ID	Title	Description
OG000	PROSTVAC-V/F-TRICOM + GM-CSF Placebo	PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).
OG001	PROSTVAC-V/F-TRICOM + GM-CSF

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PROSTVAC-V/F-TRICOM + GM-CSF Placebo	PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).	252	432	56	429	351	429
EG001	PROSTVAC-V/F-TRICOM + GM-CSF	PROSTVAC V/F + GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). GM-CSF is given SC at 100ug (on days of PROSTVAC injection and three subsequent days).	254	432	56	429	367	429
EG002	Placebo Control	Placebo PROSTVAC V/F + Placebo GM-CSF, where Placebo PROSTVAC V/F is an empty fowlpox vector (Day 1, Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).	248	433	53	428	346	428

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0011 events1 affected429 at risk EG0021 events1 affected428 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0021 events1 affected428 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Haemolytic uraemic syndrome	Blood and lymphatic system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Histiocytosis haematophagic	Blood and lymphatic system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0021 events1 affected428 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Angina pectoris	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0024 events3 affected428 at risk
Atrial flutter	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Cardiac failure	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0002 events2 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Myocardial infarction	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Retinal detachment	Eye disorders	MedDRA (18.0)	Non-systematic Assessment	EG0002 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0021 events1 affected428 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Constipation	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Gastritis	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Ileus	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Inguinal hernia strangulated	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Nausea	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0022 events2 affected428 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Proctitis	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Vomiting	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0002 events2 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Death	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
General physical health deterioration	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Non-cardiac chest pain	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Pain	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0012 events2 affected429 at risk EG0020 events0 affected428 at risk
Pyrexia	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Appendiceal abscess	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Bacterial infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Bronchopneumonia	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Catheter site infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Cellulitis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Gastroenteritis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Lobar pneumonia	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Oral candidiasis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Perinephric abscess	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Pneumonia	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0012 events2 affected429 at risk EG0021 events1 affected428 at risk
Pyelonephritis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Sepsis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Spinal cord infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0012 events2 affected429 at risk EG0020 events0 affected428 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Urinary tract infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0013 events3 affected429 at risk EG0021 events1 affected428 at risk
Urosepsis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0003 events2 affected429 at risk EG0010 events0 affected429 at risk EG0022 events2 affected428 at risk
Viral infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0021 events1 affected428 at risk
Brain herniation	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Cystitis radiation	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Gun shot wound	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Hepatic haematoma	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Radiation oesophagitis	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Spinal cord injury	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Vascular bypass dysfunction	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Blood creatinine increased	Investigations	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Troponin increased	Investigations	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Cell death	Metabolism and nutrition disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0021 events1 affected428 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Gout	Metabolism and nutrition disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0022 events2 affected428 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Carcinoma in situ of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0021 events1 affected428 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0011 events1 affected429 at risk EG0021 events1 affected428 at risk
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Metastatic pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0022 events2 affected428 at risk
Neuroendocrine carcinoma of the skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Cerebral haematoma	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0021 events1 affected428 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0012 events2 affected429 at risk EG0022 events1 affected428 at risk
Cervical cord compression	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0012 events2 affected429 at risk EG0020 events0 affected428 at risk
Nerve compression	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Presyncope	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Radiculopathy	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Spinal cord compression	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0014 events4 affected429 at risk EG0022 events2 affected428 at risk
Syncope	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0022 events2 affected428 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Confusional state	Psychiatric disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Delirium	Psychiatric disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0011 events1 affected429 at risk EG0021 events1 affected428 at risk
Dysuria	Renal and urinary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Haematuria	Renal and urinary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0004 events2 affected429 at risk EG0018 events7 affected429 at risk EG0024 events4 affected428 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0005 events5 affected429 at risk EG0011 events1 affected429 at risk EG0022 events2 affected428 at risk
Obstructive uropathy	Renal and urinary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Pyelocaliectasis	Renal and urinary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Renal failure	Renal and urinary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0003 events2 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0022 events2 affected428 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Urinary retention	Renal and urinary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0006 events6 affected429 at risk EG0014 events4 affected429 at risk EG0021 events1 affected428 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0012 events2 affected429 at risk EG0020 events0 affected428 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0005 events5 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Aortic aneurysm	Vascular disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Aortic stenosis	Vascular disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Intermittent claudication	Vascular disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk
Lymphoedema	Vascular disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected429 at risk EG0020 events0 affected428 at risk
Vascular compression	Vascular disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected429 at risk EG0020 events0 affected428 at risk
Venous thrombosis limb	Vascular disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected429 at risk EG0021 events1 affected428 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG00044 events39 affected429 at risk EG00129 events26 affected429 at risk EG00231 events28 affected428 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG00041 events38 affected429 at risk EG00131 events28 affected429 at risk EG00222 events21 affected428 at risk
Nausea	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG00065 events51 affected429 at risk EG00162 events51 affected429 at risk EG00241 events36 affected428 at risk
Asthenia	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG00046 events32 affected429 at risk EG00150 events37 affected429 at risk EG00252 events49 affected428 at risk
Chills	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG00050 events34 affected429 at risk EG00160 events44 affected429 at risk EG00242 events35 affected428 at risk
Fatigue	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG000117 events94 affected429 at risk EG001149 events105 affected429 at risk EG002116 events91 affected428 at risk
Influenza like illness	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG00068 events44 affected429 at risk EG00186 events55 affected429 at risk EG00263 events36 affected428 at risk
Injection site erythema	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG000594 events201 affected429 at risk EG001765 events256 affected429 at risk EG002626 events200 affected428 at risk
Injection site induration	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG00098 events46 affected429 at risk EG001140 events67 affected429 at risk EG002128 events58 affected428 at risk
Injection site oedema	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG00041 events22 affected429 at risk EG00147 events23 affected429 at risk EG00245 events19 affected428 at risk
Injection site pain	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG000252 events109 affected429 at risk EG001247 events128 affected429 at risk EG002247 events119 affected428 at risk
Injection site pruritus	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG000145 events77 affected429 at risk EG001235 events109 affected429 at risk EG002124 events57 affected428 at risk
Injection site swelling	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG000187 events73 affected429 at risk EG001247 events101 affected429 at risk EG002183 events67 affected428 at risk
Injection site warmth	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG00031 events15 affected429 at risk EG00155 events28 affected429 at risk EG00238 events21 affected428 at risk
Oedema peripheral	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG00022 events21 affected429 at risk EG00124 events24 affected429 at risk EG00212 events12 affected428 at risk
Pyrexia	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG00050 events37 affected429 at risk EG001142 events91 affected429 at risk EG00263 events53 affected428 at risk
Urinary tract infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG00028 events23 affected429 at risk EG00122 events17 affected429 at risk EG00228 events22 affected428 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (18.0)	Non-systematic Assessment	EG00043 events39 affected429 at risk EG00129 events25 affected429 at risk EG00233 events31 affected428 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG00070 events49 affected429 at risk EG00169 events50 affected429 at risk EG00271 events55 affected428 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG00070 events62 affected429 at risk EG00146 events43 affected429 at risk EG00255 events48 affected428 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG00015 events15 affected429 at risk EG00133 events28 affected429 at risk EG00227 events21 affected428 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG00046 events36 affected429 at risk EG00147 events35 affected429 at risk EG00261 events43 affected428 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG00034 events28 affected429 at risk EG00128 events28 affected429 at risk EG00226 events23 affected428 at risk
Dizziness	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG00020 events18 affected429 at risk EG00119 events17 affected429 at risk EG00225 events22 affected428 at risk
Headache	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG00067 events32 affected429 at risk EG00161 events43 affected429 at risk EG00245 events36 affected428 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG00026 events25 affected429 at risk EG00124 events20 affected429 at risk EG00216 events15 affected428 at risk
Hot flush	Vascular disorders	MedDRA (18.0)	Non-systematic Assessment	EG00024 events23 affected429 at risk EG00121 events20 affected429 at risk EG00215 events12 affected428 at risk
Hypertension	Vascular disorders	MedDRA (18.0)	Non-systematic Assessment	EG00033 events28 affected429 at risk EG00126 events23 affected429 at risk EG00225 events22 affected428 at risk

ID	Term
D009362	Neoplasm Metastasis
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases

ID	Term
C588274	PROSTVAC
D016178	Granulocyte-Macrophage Colony-Stimulating Factor

Ancestor Terms

ID	Term
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates
D016298	Hematopoietic Cell Growth Factors
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors

PROSTVAC V/F + GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). GM-CSF is given SC at 100ug (on days of PROSTVAC injection and three subsequent days).