A Study for Patients With Head and Neck Cancer | NCT00415194

ID	Type	Description	Link
H3E-MC-JMHR	Other Identifier	Eli Lilly and Company

Label	Type	Description	Intervention Names
Pemetrexed/Cisplatin	Experimental	Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days. Pretreatment, Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.	Drug: pemetrexed Drug: cisplatin
Placebo/Cisplatin	Placebo Comparator	Placebo (approximately 100 mL normal saline) administered intravenously (IV) plus cisplatin 75 mg/m^2 on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.	Drug: cisplatin Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
pemetrexed	Drug	500 mg/m^2, IV, every 21 days, six 21 day cycles	Pemetrexed/Cisplatin

Measure	Description	Time Frame
Overall Survival (OS)	OS duration is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date, OS duration will be censored at the date of the participant's last contact prior to that cut-off date.	Baseline to date of death from any cause up to 36 months

Measure	Description	Time Frame
Progression-free Survival (PFS)	Objective PFS is defined as the time from date of randomization to date of objectively determined progressive disease (PD) or death from any cause, whichever comes first. PD was defined by Response Evaluation Criteria in Solid Tumors (RECIST). PD=at least a 20% increase in sum of longest diameter of target lesions. For participants who are not known to have died as of the data-inclusion cut-off date, and who do not have progressive disease, PFS will be censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy.

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Orange	California	92868

ID	Title	Description
FG000	Pemetrexed/Cisplatin	Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.

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 (OS)

OS duration is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date, OS duration will be censored at the date of the participant's last contact prior to that cut-off date.

Intention to Treat (ITT) Population - defines the treatment group as those to which participants were assigned by random allocation, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.

Posted

Median

95% Confidence Interval

Months

Baseline to date of death from any cause up to 36 months

ID	Title	Description
OG000	Pemetrexed/Cisplatin	Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.
OG001	Placebo/Cisplatin	Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.

Units	Counts
Participants	OG000398 OG001397

Title

Denominators

Categories

Title	Measurements
	OG0007.33(6.34 to 8.38) OG0016.28(5.52 to 7.06)

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 OG001		Stratified Log Rank		0.082		Hazard Ratio (HR)	0.87			2-Sided	95	0.75	1.02				No	Superiority or Other

Secondary

Progression-free Survival (PFS)

Objective PFS is defined as the time from date of randomization to date of objectively determined progressive disease (PD) or death from any cause, whichever comes first. PD was defined by Response Evaluation Criteria in Solid Tumors (RECIST). PD=at least a 20% increase in sum of longest diameter of target lesions. For participants who are not known to have died as of the data-inclusion cut-off date, and who do not have progressive disease, PFS will be censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy.

Posted

Median

95% Confidence Interval

months

baseline to measured progressive disease up to 33 months

ID	Title	Description
OG000	Pemetrexed/Cisplatin	Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.

Secondary

Percent of Participants With a Tumor Response (Response Rate)

Tumor Response is evaluated as CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumors (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. Response rate (%) = (number of participants with CR+PR/number of participants)*100

Posted

Number

Percentage of participants

Baseline to progressive disease or discontinuation of study treatment up to 11 months

ID	Title	Description
OG000	Pemetrexed/Cisplatin	Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.
OG001	Placebo/Cisplatin

Secondary

Duration of Response (DoR)

DoR is time from first observation of complete response (CR) or partial response (PR) to first observation of PD or death. Response is objective status of CR or PR using RECIST criteria. CR is disappearance of lesions. PR is >30% decrease in size of lesions. Responder is any participant with CR or PR. PD is at least 20% increase in sum of longest diameter of target lesions. For participants alive as of data-inclusion cut-off date and who do not have PD, DoR will be censored at date of last objective progression-free disease assessment before date of any subsequent systemic anticancer therapy.

ITT population with a confirmed best response of complete response (CR) or partial response (PR).

Posted

Median

95% Confidence Interval

Months

time of response to progressive disease up to 24 months

ID	Title	Description
OG000	Pemetrexed/Cisplatin	Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.
OG001	Placebo/Cisplatin

Secondary

Time to Treatment Worsening in Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Total Score

FACT-H&N consists of 39 items with 5-point rating scale from 0 (not at all) to 4 (very much). FACT-H&N Total score ranges from 0 to 148. Higher score represents a better quality of life. Time to worsening was defined as the first date of worsening in the FACT H&N Total score that was considered at least the prospectively defined minimally important difference (MID) as compared with participant's baseline score, or date of death from any cause. The MID for FACT H&N Total score was a decrease of 12 points.

Intention to treat (ITT) population with at least Baseline data.

Posted

Median

95% Confidence Interval

Months

Baseline (</=Day 1 of first dose) and Day 1 of every subsequent cycle to 30-day post-study completion up to 33 months

ID	Title	Description
OG000	Pemetrexed/Cisplatin	Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.
OG001	Placebo/Cisplatin

Secondary

Correlation Between Biomarkers and Treatment Effect

Correlation between highly up/downregulated genes and clinical response (Overall Survival (OS) and Progression-Free Survival (PFS)). OS is is defined as the time from the date of randomization to the date of death from any cause. PFS is defined as the time from the date of randomization to the date of objectively determined progressive disease or death from any cause, whichever comes first.

0 participants were analyzed; Reason: The relatively low number of samples collected would not have yielded a meaningful genomic analysis and the decision was made to not analyze the data.

Zero participants were analyzed because the relatively low number of samples collected would not have yielded a meaningful genomic analysis.

Posted

Number

correlation coefficient

Baseline

ID	Title	Description
OG000	Pemetrexed/Cisplatin	Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.
OG001	Placebo/Cisplatin

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Agranulocytosis	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0006 events3 affected392 at risk EG0010 events0 affected385 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG00027 events22 affected392 at risk EG00120 events17 affected385 at risk
Anaemia of malignant disease	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Bone marrow toxicity	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG00013 events12 affected392 at risk EG0010 events0 affected385 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG00016 events14 affected392 at risk EG0011 events1 affected385 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG00013 events12 affected392 at risk EG0013 events3 affected385 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG00012 events11 affected392 at risk EG0013 events3 affected385 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0003 events3 affected392 at risk EG0010 events0 affected385 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected392 at risk EG0010 events0 affected385 at risk
Atrial flutter	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Cardiac arrest	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected392 at risk EG0010 events0 affected385 at risk
Cardiac failure	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected392 at risk EG0011 events1 affected385 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0003 events3 affected392 at risk EG0012 events2 affected385 at risk
Myocardial infarction	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0012 events2 affected385 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Tracheo-oesophageal fistula	Congenital, familial and genetic disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Deafness	Ear and labyrinth disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0004 events2 affected392 at risk EG0011 events1 affected385 at risk
Aphagia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Constipation	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected392 at risk EG0012 events2 affected385 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG00014 events14 affected392 at risk EG0011 events1 affected385 at risk
Disbacteriosis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0006 events6 affected392 at risk EG0013 events3 affected385 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Gastritis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 events1 affected392 at risk EG0010 events0 affected385 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected385 at risk
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Glossodynia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Ileus	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Intestinal infarction	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Mesenteric artery thrombosis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected392 at risk EG0013 events2 affected385 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG00014 events13 affected392 at risk EG0017 events7 affected385 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected392 at risk EG0010 events0 affected385 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected392 at risk EG0010 events0 affected385 at risk
Tongue oedema	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG00024 events22 affected392 at risk EG0019 events9 affected385 at risk
Adhesion	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Asthenia	General disorders	MedDRA 12.0	Systematic Assessment	EG0008 events6 affected392 at risk EG0019 events9 affected385 at risk
Chest pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Chills	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Death	General disorders	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected392 at risk EG0014 events4 affected385 at risk
Face oedema	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected385 at risk
Fatigue	General disorders	MedDRA 12.0	Systematic Assessment	EG0007 events7 affected392 at risk EG0015 events5 affected385 at risk
General physical health deterioration	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Influenza like illness	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Local swelling	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected385 at risk
Localised oedema	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Malaise	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected385 at risk
Mucosal inflammation	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected385 at risk
Multi-organ failure	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected385 at risk
Oedema peripheral	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0012 events2 affected385 at risk
Performance status decreased	General disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected392 at risk EG0010 events0 affected385 at risk
Pyrexia	General disorders	MedDRA 12.0	Systematic Assessment	EG0009 events9 affected392 at risk EG0017 events6 affected385 at risk
Sudden cardiac death	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Hypersensitivity	Immune system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0012 events2 affected385 at risk
Abdominal infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Abscess	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Acinetobacter infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Bronchitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Bronchopneumonia	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected392 at risk EG0010 events0 affected385 at risk
Candida sepsis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Catheter site infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Cellulitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected385 at risk
Central line infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Empyema	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Gastroenteritis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Herpes zoster	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0013 events3 affected385 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Lung infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Oral candidiasis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Oral infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected392 at risk EG0010 events0 affected385 at risk
Pneumonia	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG00029 events26 affected392 at risk EG0019 events7 affected385 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Pseudomonas infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0012 events1 affected385 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Respiratory tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected385 at risk
Sepsis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected392 at risk EG0014 events4 affected385 at risk
Septic shock	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0003 events3 affected392 at risk EG0012 events2 affected385 at risk
Skin infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Staphylococcal infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected392 at risk EG0010 events0 affected385 at risk
Superinfection bacterial	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Tracheitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Urinary tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected385 at risk
Wound infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0012 events2 affected385 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected392 at risk EG0011 events1 affected385 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Gastrostomy failure	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0002 events1 affected392 at risk EG0013 events3 affected385 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Tracheal obstruction	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Aspiration bronchial	Investigations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Blood creatinine increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected392 at risk EG0011 events1 affected385 at risk
Blood electrolytes abnormal	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Blood pressure increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Creatinine renal clearance decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0012 events2 affected385 at risk
ECG signs of myocardial ischaemia	Investigations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Glomerular filtration rate decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected385 at risk
Haemoglobin decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG0009 events7 affected392 at risk EG0014 events4 affected385 at risk
Lymphocyte count decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Neutrophil count decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Platelet count decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Weight decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG0003 events3 affected392 at risk EG0010 events0 affected385 at risk
White blood cell count decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
White blood cell count increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected392 at risk EG0010 events0 affected385 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0005 events5 affected392 at risk EG0016 events5 affected385 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected392 at risk EG0010 events0 affected385 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0009 events9 affected392 at risk EG0017 events7 affected385 at risk
Diabetic foot	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0012 events2 affected385 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected385 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0002 events1 affected392 at risk EG0012 events2 affected385 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0007 events6 affected392 at risk EG0017 events7 affected385 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0013 events2 affected385 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0009 events9 affected392 at risk EG0015 events5 affected385 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected392 at risk EG0010 events0 affected385 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Shock hypoglycaemic	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected385 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0012 events2 affected385 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Trismus	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Infected neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Intracranial tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Metastatic pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Oncologic complication	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Skin neoplasm bleeding	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0016 events4 affected385 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected392 at risk EG0011 events1 affected385 at risk
Anoxic encephalopathy	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Cerebral infarction	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected392 at risk EG0011 events1 affected385 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected385 at risk
Coma	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Convulsion	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0013 events3 affected385 at risk
Dizziness	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected385 at risk
Encephalitis	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Hydrocephalus	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Lethargy	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Loss of consciousness	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Polyneuropathy	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Spinal cord compression	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Syncope	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0004 events3 affected392 at risk EG0014 events4 affected385 at risk
Depression	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected392 at risk EG0010 events0 affected385 at risk
Disorientation	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Suicide attempt	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Renal failure	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0009 events7 affected392 at risk EG0015 events4 affected385 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0004 events3 affected392 at risk EG0012 events2 affected385 at risk
Renal impairment	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected385 at risk
Bronchial secretion retention	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected392 at risk EG0011 events1 affected385 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG00010 events10 affected392 at risk EG00115 events15 affected385 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Laryngeal dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected392 at risk EG0010 events0 affected385 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected392 at risk EG0010 events0 affected385 at risk
Pharyngeal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected392 at risk EG0011 events1 affected385 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected392 at risk EG0011 events1 affected385 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected392 at risk EG0011 events1 affected385 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected392 at risk EG0012 events2 affected385 at risk
Respiratory tract haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Stridor	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0012 events2 affected385 at risk
Upper airway obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected385 at risk
Circulatory collapse	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Embolism	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Femoral artery occlusion	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Haemodynamic instability	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected385 at risk
Haemorrhage	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0013 events3 affected385 at risk
Hypotension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected392 at risk EG0012 events1 affected385 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected392 at risk EG0010 events0 affected385 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Phlebitis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Shock	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected385 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Superior vena caval occlusion	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk
Venous thrombosis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected385 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG000133 events118 affected392 at risk EG00188 events79 affected385 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG00057 events38 affected392 at risk EG00135 events24 affected385 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG000105 events67 affected392 at risk EG00148 events35 affected385 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG00033 events28 affected392 at risk EG00122 events17 affected385 at risk
Constipation	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG00063 events56 affected392 at risk EG00165 events53 affected385 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG00050 events42 affected392 at risk EG00135 events33 affected385 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG00019 events19 affected392 at risk EG00123 events22 affected385 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG000199 events118 affected392 at risk EG001153 events106 affected385 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG00081 events62 affected392 at risk EG001104 events79 affected385 at risk
Asthenia	General disorders	MedDRA 12.0	Systematic Assessment	EG00041 events36 affected392 at risk EG00135 events31 affected385 at risk
Fatigue	General disorders	MedDRA 12.0	Systematic Assessment	EG00088 events67 affected392 at risk EG00157 events53 affected385 at risk
Mucosal inflammation	General disorders	MedDRA 12.0	Systematic Assessment	EG00030 events25 affected392 at risk EG0018 events8 affected385 at risk
Pain	General disorders	MedDRA 12.0	Systematic Assessment	EG00019 events16 affected392 at risk EG00123 events20 affected385 at risk
Pyrexia	General disorders	MedDRA 12.0	Systematic Assessment	EG00044 events40 affected392 at risk EG00121 events19 affected385 at risk
Creatinine renal clearance decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG00034 events32 affected392 at risk EG00136 events31 affected385 at risk
Weight decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG00047 events45 affected392 at risk EG00151 events50 affected385 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG00063 events52 affected392 at risk EG00150 events44 affected385 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG00028 events25 affected392 at risk EG00115 events14 affected385 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG00047 events40 affected392 at risk EG00130 events29 affected385 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG00027 events21 affected392 at risk EG00125 events24 affected385 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG00025 events23 affected392 at risk EG00126 events23 affected385 at risk
Insomnia	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG00024 events23 affected392 at risk EG00123 events23 affected385 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG00025 events23 affected392 at risk EG00121 events20 affected385 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG00019 events18 affected392 at risk EG00121 events21 affected385 at risk

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pemetrexed/Cisplatin	Pemetrexed 500 milligrams per meter square (mg/m2) administered intravenously (IV) plus cisplatin 75 mg/m2 IV on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.			185	392	343	392
EG001	Placebo/Cisplatin	Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m2 on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.			132	385	316	385

ID	Term
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D005971	Glutamates
D024342	Amino Acids, Acidic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000600	Amino Acids, Dicarboxylic
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds

ID	Title	Description
BG000	Pemetrexed/Cisplatin	Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.
BG001	Placebo/Cisplatin	Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.
BG002	Total	Total of all reporting groups