A Study of Induction and Maintenance Treatment of Advance... | NCT00789373

ID	Type	Description	Link
H3E-EW-S124	Other Identifier	Eli Lilly and Company
CTRI/2009/091/000113	Registry Identifier	India

Label	Type	Description	Intervention Names
pemetrexed + cisplatin followed by pemetrexed	Experimental	pemetrexed plus cisplatin followed by pemetrexed plus best supportive care	Drug: Pemetrexed Drug: Cisplatin Other: Best Supportive Care
pemetrexed + cisplatin followed by placebo	Placebo Comparator	pemetrexed plus cisplatin followed by placebo plus best supportive care	Drug: Pemetrexed Drug: Cisplatin Drug: Placebo Other: Best Supportive Care

Name	Type	Description	Arm Group Labels	Other Names
Pemetrexed	Drug	Induction therapy: 500 mg/m^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles	pemetrexed + cisplatin followed by pemetrexed pemetrexed + cisplatin followed by placebo

Measure	Description	Time Frame
Investigator-assessed Objective Progression-free Survival (PFS)	Investigator-assessed objective PFS was measured from the date of randomization to the first date of objectively determined progressive disease (PD) or death from any cause. For patients not known to have died as of the data cutoff date and who did not have objective PD, PFS was censored at the date of last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.	Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months)

Measure	Description	Time Frame
Independently-assessed Objective Progression-free Survival (PFS)	To further evaluate the robustness of the PFS analysis, Lilly established an independent review of PFS to assess the potential for investigator bias in the determination of objective PD. PFS was measured from the date of randomization to the first date of objectively determined PD or death. For patients alive as of the data cutoff date and who did not have PD, PFS was censored at the date of the last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.

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.		Adelaide	South Australia	5000

PubMed Identifier	Type	Citation	Retractions
29424248	Derived	Middleton G, Gridelli C, De Marinis F, Pujol JL, Reck M, Ramlau R, Parente B, Pieters T, Visseren-Grul CM, San Antonio B, John WJ, Zimmermann AH, Chouaki N, Paz-Ares L. Evaluation of changes in renal function in PARAMOUNT: a phase III study of maintenance pemetrexed plus best supportive care versus placebo plus best supportive care after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. Curr Med Res Opin. 2018 May;34(5):865-871. doi: 10.1080/03007995.2018.1439462. Epub 2018 Mar 27.
25104617

ID	Title	Description
FG000	Induction Pemetrexed + Cisplatin	pemetrexed: 500 mg/m^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles. cisplatin: 75 mg/m^2, IV, on Day 1 of each 21-day cycle for 4 cycles.
FG001	Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed

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

Investigator-assessed Objective Progression-free Survival (PFS)

Investigator-assessed objective PFS was measured from the date of randomization to the first date of objectively determined progressive disease (PD) or death from any cause. For patients not known to have died as of the data cutoff date and who did not have objective PD, PFS was censored at the date of last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.

All randomized participants

Posted

Median

95% Confidence Interval

months

Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months)

ID	Title	Description
OG000	Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed	pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
OG001	Pemetrexed + Cisplatin Followed by Placebo	pemetrexed + cisplatin followed by placebo plus best supportive care

Units	Counts
Participants	OG000359 OG001180

Title

Denominators

Categories

Title	Measurements
	OG0004.11(3.15 to 4.57) OG0012.83(2.60 to 3.12)

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	900 patients were planned to be enrolled in order to randomize 558 pts to maintenance therapy. This trial was powered for the primary endpoint, PFS (90% power, assuming 238 events with 52% censoring and a PFS Hazard Ratio (HR)=0.65, alpha=0.05). This trial was also powered for a secondary endpoint, OS (93% power, assuming 390 events with 30% censoring and an OS HR=0.70). Alpha was controlled for both a preliminary analysis (alpha=0.0001) and final analysis of OS (alpha=0.0499).	Log Rank		0.00006		Hazard Ratio (HR)	0.62			2-Sided	95	0.49	0.79					Superiority or Other

Secondary

Independently-assessed Objective Progression-free Survival (PFS)

To further evaluate the robustness of the PFS analysis, Lilly established an independent review of PFS to assess the potential for investigator bias in the determination of objective PD. PFS was measured from the date of randomization to the first date of objectively determined PD or death. For patients alive as of the data cutoff date and who did not have PD, PFS was censored at the date of the last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.

Randomized participants with reviewable scan--(316/359 [88%] Maintenance arm and 156/180 [87%] Placebo comparator arm. The majority of unread scans (12.4%) were due to participants not completing 1 cycle of treatment by the data cutoff date (30 June 2010).

Posted

Median

95% Confidence Interval

months

Date of randomization to first date of measured PD or date of death from any cause (up to 19.3 months)

ID	Title	Description
OG000	Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed	pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
OG001	Pemetrexed + Cisplatin Followed by Placebo	pemetrexed + cisplatin followed by placebo plus best supportive care

Secondary

Overall Survival (OS)

OS is the duration from enrollment to death. For patients who are alive, OS is censored at the last contact.

All randomized participants. In the Pemetrexed maintenance arm 103 (28.7%) participants were censored and in the Placebo maintenance arm 39 (21.7%) participants were censored.

Posted

Median

95% Confidence Interval

months

Date of randomization to the date of death from any cause up to 39.5 months

ID	Title	Description
OG000	Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed	pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
OG001	Pemetrexed + Cisplatin Followed by Placebo	pemetrexed and cisplatin followed by placebo plus best supportive care

Units	Counts
Participants	OG000

Secondary

Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score

The EQ-5D is a generic instrument that describes health status in 5 attributes (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) using a three level scale (no problem, some problems, and major problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score range from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).

Participants who were randomized and completed the EQ-5D at baseline and at least once post-baseline. For Cycle 17 and 18, there is no data available for the pemetrexed + cisplatin followed by placebo arm. No participants completed so zero participants were analyzed.

Posted

Mean

Standard Deviation

units on a scale

Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)

ID	Title	Description
OG000	Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed	pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
OG001	Pemetrexed + Cisplatin Followed by Placebo	pemetrexed + cisplatin followed by placebo plus best supportive care

Secondary

Change From Baseline in EuroQol Instrument (EQ-5D) Visual Analog Scale (VAS)

Patients indicate their present health state through completion of the VAS. Possible scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).

Posted

Mean

Standard Deviation

units on a scale

Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)

ID	Title	Description
OG000	Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed	pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
OG001	Pemetrexed + Cisplatin Followed by Placebo	pemetrexed + cisplatin followed by placebo plus best supportive care

Units	Counts
Participants

Secondary

Percentage of Participants With Hospitalizations Due to Adverse Events or Requiring Transfusion (Resource Utilization)

All randomized participants

Posted

Number

percentage of participants

Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)

ID	Title	Description
OG000	Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed	pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
OG001	Pemetrexed + Cisplatin Followed by Placebo	pemetrexed + cisplatin followed by placebo plus best supportive care

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With a Non-Serious Adverse Event (AE) During Maintenance Phase

A summary of non-serious AEs is located in the Reported Adverse Event Module.

Randomized population with 2% cut-off threshold for inclusion for 19.3 months and 5% for 49.7 months.

Posted

Number

percentage of participants

Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months)

ID	Title	Description
OG000	Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed	pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
OG001	Pemetrexed Plus Cisplatin Followed by Placebo	pemetrexed + cisplatin followed by placebo plus best supportive care

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Serious Adverse Events During Maintenance Phase

A summary of serious adverse events is located in the Reported Adverse Event Module.

Randomized population with all serious adverse events included.

Posted

Number

percentage of participants

Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months)

ID	Title	Description
OG000	Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed	pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
OG001	Pemetrexed Plus Cisplatin Followed by Placebo	pemetrexed + cisplatin followed by placebo plus best supportive care

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Objective Tumor Response (Response Rate) During Maintenance Phase of Study up to Primary Data Cut-Off

Analysis for combined phases was not performed since response was calculated separately for each phase of study. Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response(PR)is at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease(PD) is at least a 20% increase in sum of longest diameter of target lesions; Stable Disease(SD)=no change or small changes that do not meet the above criteria for CR, PR, or PD.

All randomized participants

Posted

Number

percentage of participants

Baseline to date of measured progressive disease (up to 19.3 months)

ID	Title	Description
OG000	Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed	pemetrexed and cisplatin followed by maintenance pemetrexed and best supportive care
OG001	Pemetrexed + Cisplatin Followed by Placebo	pemetrexed + cisplatin followed by placebo plus best supportive care

Units	Counts

Secondary

Percentage of Participants With Independently-Assessed Objective Tumor Response (Response Rate) During Maintenance Phase Up to Primary Data Cut-Off

Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) is at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=no change or small changes that do not meet the above criteria for CR, PR, or PD. Response Rate = (CR+PR)/Participants in Arm*100. Disease Control Rate=(CR+PR+SD)/Number of Participants in Arm*100.

All randomized participants

Posted

Number

95% Confidence Interval

percentage of participants

Date of randomization to date of measured PD (up to 19.3 months)

ID	Title	Description
OG000	Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed	pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
OG001	Pemetrexed + Cisplatin Followed by Placebo	pemetrexed + cisplatin followed by placebo plus best supportive care

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00030 events13 affected939 at risk EG00121 events11 affected359 at risk EG0021 events1 affected180 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0012 events1 affected359 at risk EG0020 events0 affected180 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00013 events12 affected939 at risk EG0016 events6 affected359 at risk EG0020 events0 affected180 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected939 at risk EG0013 events2 affected359 at risk EG0020 events0 affected180 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0009 events8 affected939 at risk EG0018 events6 affected359 at risk EG0020 events0 affected180 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0009 events7 affected939 at risk EG0018 events5 affected359 at risk EG0020 events0 affected180 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0011 events1 affected359 at risk EG0020 events0 affected180 at risk
Arrhythmia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0011 events1 affected359 at risk EG0020 events0 affected180 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0004 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Atrial thrombosis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0005 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Cardiac arrest	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected939 at risk EG0010 events0 affected359 at risk EG0021 events1 affected180 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Diastolic dysfunction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Myocardial infarction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Palpitations	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Pericardial effusion	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected939 at risk EG0010 events0 affected359 at risk EG0022 events1 affected180 at risk
Pericarditis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0006 events1 affected939 at risk EG0015 events2 affected359 at risk EG0020 events0 affected180 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0011 events1 affected359 at risk EG0020 events0 affected180 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Cataract	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG00114 events1 affected359 at risk EG0020 events0 affected180 at risk
Diabetic retinopathy	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0016 events1 affected359 at risk EG0020 events0 affected180 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0012 events1 affected359 at risk EG0020 events0 affected180 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00011 events3 affected939 at risk EG0014 events3 affected359 at risk EG0020 events0 affected180 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0010 events0 affected359 at risk EG0021 events1 affected180 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0011 events1 affected359 at risk EG0020 events0 affected180 at risk
Ascites	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0016 events2 affected359 at risk EG0020 events0 affected180 at risk
Colitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Constipation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0008 events6 affected939 at risk EG0011 events1 affected359 at risk EG0021 events1 affected180 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0009 events7 affected939 at risk EG0013 events3 affected359 at risk EG0020 events0 affected180 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0006 events4 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0011 events1 affected359 at risk EG0020 events0 affected180 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events1 affected939 at risk EG0012 events1 affected359 at risk EG0020 events0 affected180 at risk
Gastritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0012 events1 affected359 at risk EG0021 events1 affected180 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected939 at risk EG0011 events1 affected359 at risk EG0020 events0 affected180 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Ileus	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0016 events3 affected359 at risk EG0020 events0 affected180 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00041 events24 affected939 at risk EG0015 events2 affected359 at risk EG0021 events1 affected180 at risk
Neutropenic colitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0021 events1 affected180 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0010 events0 affected359 at risk EG0021 events1 affected180 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0011 events1 affected359 at risk EG0020 events0 affected180 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00036 events29 affected939 at risk EG0013 events3 affected359 at risk EG0021 events1 affected180 at risk
Asthenia	General disorders	MedDRA 21.0	Systematic Assessment	EG0009 events5 affected939 at risk EG0014 events2 affected359 at risk EG0020 events0 affected180 at risk
Chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG00017 events7 affected939 at risk EG00117 events3 affected359 at risk EG0020 events0 affected180 at risk
Death	General disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected939 at risk EG0011 events1 affected359 at risk EG0020 events0 affected180 at risk
Fatigue	General disorders	MedDRA 21.0	Systematic Assessment	EG00022 events7 affected939 at risk EG0014 events3 affected359 at risk EG0023 events1 affected180 at risk
General physical health deterioration	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Mucosal inflammation	General disorders	MedDRA 21.0	Systematic Assessment	EG00010 events7 affected939 at risk EG0012 events1 affected359 at risk EG0020 events0 affected180 at risk
Multi-organ failure	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Non-cardiac chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0011 events1 affected359 at risk EG0020 events0 affected180 at risk
Oedema peripheral	General disorders	MedDRA 21.0	Systematic Assessment	EG0003 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG00013 events10 affected939 at risk EG0015 events4 affected359 at risk EG0022 events2 affected180 at risk
Sudden death	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0011 events1 affected359 at risk EG0021 events1 affected180 at risk
Thrombosis in device	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0010 events0 affected359 at risk EG00210 events1 affected180 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0011 events1 affected359 at risk EG0020 events0 affected180 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0012 events1 affected359 at risk EG0020 events0 affected180 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0012 events1 affected359 at risk EG0020 events0 affected180 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0012 events1 affected359 at risk EG0020 events0 affected180 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Anal abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0011 events1 affected359 at risk EG0020 events0 affected180 at risk
Bronchopneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0015 events2 affected359 at risk EG0020 events0 affected180 at risk
Cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0017 events3 affected359 at risk EG0020 events0 affected180 at risk
Device related infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events2 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Endocarditis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0011 events1 affected359 at risk EG0020 events0 affected180 at risk
Erysipelas	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG00110 events3 affected359 at risk EG0020 events0 affected180 at risk
Gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0012 events2 affected359 at risk EG0020 events0 affected180 at risk
Herpes zoster	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected939 at risk EG0012 events1 affected359 at risk EG0020 events0 affected180 at risk
Lobar pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0012 events1 affected359 at risk EG0020 events0 affected180 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected939 at risk EG0013 events2 affected359 at risk EG0021 events1 affected180 at risk
Lung abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Lung infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Lung infection pseudomonal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0011 events1 affected359 at risk EG0020 events0 affected180 at risk
Oral candidiasis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Peritonitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00025 events17 affected939 at risk EG0018 events5 affected359 at risk EG0023 events3 affected180 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Postoperative wound infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Pyelonephritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0010 events0 affected359 at risk EG0021 events1 affected180 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0011 events1 affected359 at risk EG0020 events0 affected180 at risk
Respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected939 at risk EG0013 events2 affected359 at risk EG0020 events0 affected180 at risk
Rotavirus infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Scrotal abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected577 at risk EG0010 events0 affected201 at risk EG0021 events1 affected112 at risk
Sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0021 events1 affected180 at risk
Septic shock	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Staphylococcal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected939 at risk EG0010 events0 affected359 at risk EG0023 events1 affected180 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected939 at risk EG0012 events2 affected359 at risk EG0021 events1 affected180 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected939 at risk EG0011 events1 affected359 at risk EG0020 events0 affected180 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0012 events1 affected359 at risk EG0020 events0 affected180 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0011 events1 affected359 at risk EG0020 events0 affected180 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Fracture displacement	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0010 events0 affected359 at risk EG0026 events1 affected180 at risk
Tracheal obstruction	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0011 events1 affected359 at risk EG0020 events0 affected180 at risk
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Venous injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Biopsy pleura	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Blood creatinine decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0012 events1 affected359 at risk EG0020 events0 affected180 at risk
Blood creatinine increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Blood sodium decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
C-reactive protein increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Creatinine renal clearance decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Haemoglobin decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Liver function test abnormal	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Weight decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected939 at risk EG0013 events1 affected359 at risk EG0020 events0 affected180 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00012 events11 affected939 at risk EG0012 events1 affected359 at risk EG0021 events1 affected180 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0013 events1 affected359 at risk EG0020 events0 affected180 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0004 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0011 events1 affected359 at risk EG0020 events0 affected180 at risk
Hypercreatininaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0005 events2 affected939 at risk EG0010 events0 affected359 at risk EG0021 events1 affected180 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0011 events1 affected359 at risk EG0021 events1 affected180 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0011 events1 affected359 at risk EG0020 events0 affected180 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0006 events4 affected939 at risk EG0012 events1 affected359 at risk EG0028 events4 affected180 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected939 at risk EG0019 events1 affected359 at risk EG0020 events0 affected180 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0014 events1 affected359 at risk EG0020 events0 affected180 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0004 events2 affected939 at risk EG0011 events1 affected359 at risk EG0020 events0 affected180 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0011 events1 affected359 at risk EG0020 events0 affected180 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00036 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0006 events4 affected939 at risk EG0010 events0 affected359 at risk EG0025 events1 affected180 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected939 at risk EG0017 events1 affected359 at risk EG0020 events0 affected180 at risk
Spinal disorder	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0013 events1 affected359 at risk EG0020 events0 affected180 at risk
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0004 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG00011 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Tumour necrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0012 events1 affected359 at risk EG0020 events0 affected180 at risk
Cerebellar infarction	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0012 events1 affected359 at risk EG0020 events0 affected180 at risk
Cerebral infarction	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0009 events4 affected939 at risk EG0012 events1 affected359 at risk EG0020 events0 affected180 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0009 events6 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Convulsion	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0010 events0 affected359 at risk EG0022 events2 affected180 at risk
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0006 events4 affected939 at risk EG0014 events2 affected359 at risk EG0020 events0 affected180 at risk
Encephalopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0012 events1 affected359 at risk EG0020 events0 affected180 at risk
Facial paresis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0014 events1 affected359 at risk EG0020 events0 affected180 at risk
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG00119 events5 affected359 at risk EG0020 events0 affected180 at risk
Hemiplegia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0018 events1 affected359 at risk EG0020 events0 affected180 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0011 events1 affected359 at risk EG0020 events0 affected180 at risk
Loss of consciousness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Paraesthesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0013 events1 affected359 at risk EG0020 events0 affected180 at risk
Paraplegia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0010 events0 affected359 at risk EG0022 events1 affected180 at risk
Pyramidal tract syndrome	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Speech disorder	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Syncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0011 events1 affected359 at risk EG0022 events1 affected180 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected362 at risk EG0010 events0 affected158 at risk EG0020 events0 affected68 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected362 at risk EG0010 events0 affected158 at risk EG0020 events0 affected68 at risk
Anxiety	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Confusional state	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0013 events1 affected359 at risk EG0020 events0 affected180 at risk
Depression	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0012 events1 affected359 at risk EG0020 events0 affected180 at risk
Hallucination	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0003 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Bladder diverticulum	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0011 events1 affected359 at risk EG0020 events0 affected180 at risk
Incontinence	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0006 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Renal failure	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0007 events5 affected939 at risk EG0017 events4 affected359 at risk EG0020 events0 affected180 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0009 events7 affected939 at risk EG0011 events1 affected359 at risk EG0020 events0 affected180 at risk
Renal impairment	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0004 events2 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Urinary retention	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Testicular pain	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0003 events1 affected577 at risk EG0010 events0 affected201 at risk EG0020 events0 affected112 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0011 events1 affected359 at risk EG0020 events0 affected180 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0010 events0 affected359 at risk EG0021 events1 affected180 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0013 events1 affected359 at risk EG0024 events1 affected180 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00026 events15 affected939 at risk EG00112 events6 affected359 at risk EG0024 events3 affected180 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0006 events3 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0010 events0 affected359 at risk EG0021 events1 affected180 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0010 events0 affected359 at risk EG0022 events1 affected180 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00028 events11 affected939 at risk EG0013 events3 affected359 at risk EG0021 events1 affected180 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0010 events0 affected359 at risk EG0022 events1 affected180 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0011 events1 affected359 at risk EG0022 events1 affected180 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0011 events1 affected359 at risk EG0021 events1 affected180 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00063 events28 affected939 at risk EG00114 events3 affected359 at risk EG0027 events3 affected180 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0013 events1 affected359 at risk EG0020 events0 affected180 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0010 events0 affected359 at risk EG0021 events1 affected180 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected939 at risk EG0010 events0 affected359 at risk EG0021 events1 affected180 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0006 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Catheter removal	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Arterial thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Arterial thrombosis limb	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0012 events1 affected359 at risk EG0020 events0 affected180 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0006 events4 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0006 events2 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Iliac artery thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG00111 events1 affected359 at risk EG0020 events0 affected180 at risk
Ischaemic limb pain	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Jugular vein distension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0010 events0 affected359 at risk EG0022 events2 affected180 at risk
Superior vena caval occlusion	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected939 at risk EG0013 events1 affected359 at risk EG0020 events0 affected180 at risk
Thrombophlebitis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected939 at risk EG0010 events0 affected359 at risk EG0020 events0 affected180 at risk

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

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	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Induction Pemetrexed + Cisplatin	pemetrexed: 500 mg/m^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles. cisplatin: 75 mg/m^2, IV, on Day 1 of each 21-day cycle for 4 cycles.	257	939	759	939
EG001	Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed	pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care	94	359	287	359
EG002	Pemetrexed + Cisplatin Followed by Placebo	pemetrexed and cisplatin followed by placebo plus best supportive care	36	180	117	180