Study of Pemetrexed and Carboplatin Compared With Etoposi... | NCT00363415

ID	Type	Description	Link
H3E-MC-JMHO

Label	Type	Description	Intervention Names
A	Experimental		Drug: pemetrexed Drug: carboplatin
B	Active Comparator		Drug: etoposide Drug: carboplatin

Name	Type	Description	Arm Group Labels	Other Names
pemetrexed	Drug	500 mg/m2, intravenous (IV), every 21 days x 6 cycles	A

Measure	Description	Time Frame
Overall Survival	Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.	baseline to date of death from any cause (up to 19.6 months)

Measure	Description	Time Frame
Overall Survival (Subgroups)	The effects of individual baseline factors (sex, race, Eastern Cooperative Oncology Group (ECOG) performance, region, lactate dehydrogenase (LDH), age, number of metastatic sites, and history of brain metastases) on overall survival are reported. For two subgroups - LDH<=upper limit of normal and brain metastases=yes, the upper limits of the 95% confidence interval were not calculable for the etoposide+carboplatin group - instead the number of participants in these two subgroups are presented as a post-hoc outcome measure.

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.		Huntsville	Alabama	35805

PubMed Identifier	Type	Citation	Retractions
36184621	Derived	Ventz S, Khozin S, Louv B, Sands J, Wen PY, Rahman R, Comment L, Alexander BM, Trippa L. The design and evaluation of hybrid controlled trials that leverage external data and randomization. Nat Commun. 2022 Oct 2;13(1):5783. doi: 10.1038/s41467-022-33192-1.
19720897	Derived	Socinski MA, Smit EF, Lorigan P, Konduri K, Reck M, Szczesna A, Blakely J, Serwatowski P, Karaseva NA, Ciuleanu T, Jassem J, Dediu M, Hong S, Visseren-Grul C, Hanauske AR, Obasaju CK, Guba SC, Thatcher N. Phase III study of pemetrexed plus carboplatin compared with etoposide plus carboplatin in chemotherapy-naive patients with extensive-stage small-cell lung cancer. J Clin Oncol. 2009 Oct 1;27(28):4787-92. doi: 10.1200/JCO.2009.23.1548. Epub 2009 Aug 31.

ID	Title	Description
FG000	Pemetrexed + Carboplatin	Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
FG001	Etoposide + Carboplatin

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

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

Number of participants with events. In the pemetrexed+carboplatin group, 242 participants were censored. In the etoposide+carboplatin group, 288 participants were censored.

Posted

Median

95% Confidence Interval

months

baseline to date of death from any cause (up to 19.6 months)

ID	Title	Description
OG000	Pemetrexed + Carboplatin	Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
OG001	Etoposide + Carboplatin	Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles

Units	Counts
Participants	OG000211 OG001167

Title

Denominators

Categories

Title	Measurements
	OG0008.1(7.3 to 9.1) OG00110.6(9.7 to 11.6)

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		Log Rank		<0.01		Hazard Ratio (HR)	1.56				95	1.27	1.92				No	Superiority or Other

Secondary

Overall Survival (Subgroups)

The effects of individual baseline factors (sex, race, Eastern Cooperative Oncology Group (ECOG) performance, region, lactate dehydrogenase (LDH), age, number of metastatic sites, and history of brain metastases) on overall survival are reported. For two subgroups - LDH<=upper limit of normal and brain metastases=yes, the upper limits of the 95% confidence interval were not calculable for the etoposide+carboplatin group - instead the number of participants in these two subgroups are presented as a post-hoc outcome measure.

Number of randomized participants.

Posted

Median

95% Confidence Interval

months

baseline to date of death from any cause (up to 19.6 months)

ID	Title	Description
OG000	Pemetrexed + Carboplatin	Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
OG001	Etoposide + Carboplatin	Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles

Units	Counts
Participants

Secondary

Progression Free Survival

The period from study entry until disease progression, death or date of last contact.

All randomized participants. Number of participants censored: 113 in Pemetrexed+Carboplatin; 150 in Etoposide+Carboplatin.

Posted

Median

95% Confidence Interval

months

baseline to measured progressive disease (up to 14.7 months)

ID	Title	Description
OG000	Pemetrexed + Carboplatin	Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
OG001	Etoposide + Carboplatin	Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy - Lung (FACT-L)

FACT-L measures following domains of health-related quality of life (HR-QL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of lung cancer. Total scores range from 0 to 136, with higher scores representing better HR-QL. A clinically meaningful change is considered to be 5 points.

Number of randomized participants with baseline and non-missing value at respective cycle.

Posted

Mean

Standard Deviation

units on a scale

baseline and 6 cycles (21-day cycles)

ID	Title	Description
OG000	Pemetrexed + Carboplatin	Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
OG001	Etoposide + Carboplatin	Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles

Units	Counts
Participants

Secondary

Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes)

The effects of individual baseline factors (lactate dehydrogenase (LDH) and history of brain metastases) on overall survival are reported. The Upper Limits of the 95% Confidence Intervals were not calculable for these factors in the Etoposide+Carboplatin group. The number of participants in these subgroup are instead presented as a Post-Hoc Outcome Measure.

The upper limit of the 95% Confidence Intervals (CI) were not calculable for these two subgroups in the etoposide+carboplatin group so medians and lower limits of the 95% CI are not presented. A post-hoc outcome measure table provides the number of participants in each subgroup.

Posted

Median

95% Confidence Interval

months

baseline to date of death due to any cause (up to 19.6 months)

ID	Title	Description
OG000	Pemetrexed + Carboplatin	Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
OG001	Etoposide + Carboplatin	Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles

Post-Hoc

Number of Participants in Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes

Number of participants with Low Density Lipoprotein <=upper limit of normal and the number of participants with a history of brain metastases. This post-hoc outcome replaces the one for Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes).

Number of randomized participants.

Posted

Number

participants

baseline to date of death due to any cause (up to 19.6 months)

ID	Title	Description
OG000	Pemetrexed + Carboplatin	Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
OG001	Etoposide + Carboplatin	Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Agranulocytosis	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG00020 events18 affected433 at risk EG0017 events7 affected447 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0008 events7 affected433 at risk EG00114 events14 affected447 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected433 at risk EG0014 events4 affected447 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG00012 events11 affected433 at risk EG00121 events19 affected447 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected433 at risk EG0010 events0 affected447 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG00018 events15 affected433 at risk EG0018 events7 affected447 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0011 events1 affected447 at risk
Angina pectoris	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0011 events1 affected447 at risk
Angina unstable	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0012 events2 affected447 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0005 events5 affected433 at risk EG0010 events0 affected447 at risk
Atrial flutter	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Cardiac arrest	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected433 at risk EG0011 events1 affected447 at risk
Cardiac failure	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected433 at risk EG0010 events0 affected447 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0011 events1 affected447 at risk
Cardiac fibrillation	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected433 at risk EG0011 events1 affected447 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Myocardial infarction	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected433 at risk EG0011 events1 affected447 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Tracheo-oesophageal fistula	Congenital, familial and genetic disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0012 events2 affected447 at risk
Eyelid ptosis	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Retinal detachment	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected433 at risk EG0011 events1 affected447 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected433 at risk EG0012 events2 affected447 at risk
Colitis	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected433 at risk EG0010 events0 affected447 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected433 at risk EG0014 events4 affected447 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00011 events11 affected433 at risk EG0013 events3 affected447 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected433 at risk EG0011 events1 affected447 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Gastritis	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Gastroduodenal ulcer	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00018 events15 affected433 at risk EG0012 events2 affected447 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0012 events2 affected447 at risk
Oral discomfort	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0012 events2 affected447 at risk
Proctitis	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00011 events11 affected433 at risk EG0014 events4 affected447 at risk
Asthenia	General disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected433 at risk EG0012 events2 affected447 at risk
Chest discomfort	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Chest pain	General disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected433 at risk EG0014 events4 affected447 at risk
Condition aggravated	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Fatigue	General disorders	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected433 at risk EG0012 events2 affected447 at risk
General physical health deterioration	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Malaise	General disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected433 at risk EG0010 events0 affected447 at risk
Mucosal inflammation	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Pain	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Performance status decreased	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0012 events2 affected447 at risk
Pyrexia	General disorders	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected433 at risk EG0016 events5 affected447 at risk
Sudden death	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Visceral oedema	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Hepatic pain	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Anaphylactic shock	Immune system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Hypersensitivity	Immune system disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Bacterial sepsis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Bronchopneumonia	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0011 events1 affected447 at risk
Candidiasis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Catheter related infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Cellulitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Device related infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Diverticulitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0011 events1 affected447 at risk
Empyema	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected433 at risk EG0013 events2 affected447 at risk
Encephalitis herpes	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Enteritis infectious	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Febrile infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Gastroenteritis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Herpes zoster	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Klebsiella sepsis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected433 at risk EG0010 events0 affected447 at risk
Lung abscess	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Lung infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected433 at risk EG0010 events0 affected447 at risk
Necrotising fasciitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0012 events2 affected447 at risk
Pneumonia	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00024 events20 affected433 at risk EG00116 events15 affected447 at risk
Pneumonia necrotising	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Pneumonia primary atypical	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0011 events1 affected447 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Respiratory tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0013 events3 affected447 at risk
Sepsis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0005 events5 affected433 at risk EG0015 events5 affected447 at risk
Septic shock	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected433 at risk EG0010 events0 affected447 at risk
Staphylococcal infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0012 events2 affected447 at risk
Urinary tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected433 at risk EG0013 events3 affected447 at risk
Wound infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 events1 affected433 at risk EG0010 events0 affected447 at risk
Drug toxicity	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Lung injury	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Poisoning	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Blood bilirubin increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Blood creatinine increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected433 at risk EG0011 events1 affected447 at risk
Blood urea increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
C-reactive protein increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Platelet count decreased	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0011 events1 affected447 at risk
Weight decreased	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
White blood cell count decreased	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected433 at risk EG0010 events0 affected447 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0006 events6 affected433 at risk EG0015 events4 affected447 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected433 at risk EG0010 events0 affected447 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected433 at risk EG0010 events0 affected447 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0006 events6 affected433 at risk EG0015 events5 affected447 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0012 events2 affected447 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected433 at risk EG0011 events1 affected447 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Intracranial tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Metastatic pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Tumour lysis syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Ataxia	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Convulsion	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected433 at risk EG0016 events6 affected447 at risk
Diplegia	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Encephalopathy	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Epilepsy	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Hemiparesis	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Lethargy	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Nervous system disorder	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Speech disorder	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Spinal cord compression	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Unresponsive to stimuli	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Vocal cord paralysis	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Confusional state	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0012 events2 affected447 at risk
Insomnia	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0011 events1 affected447 at risk
Panic attack	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Tobacco withdrawal symptoms	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Haematuria	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Renal failure	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0005 events5 affected433 at risk EG0011 events1 affected447 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected433 at risk EG0011 events1 affected447 at risk
Urinary retention	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0012 events2 affected447 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Bronchial secretion retention	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0011 events1 affected447 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00016 events15 affected433 at risk EG00115 events15 affected447 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected433 at risk EG0013 events3 affected447 at risk
Hydropneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0013 events3 affected447 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0011 events1 affected447 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0011 events1 affected447 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected433 at risk EG0013 events3 affected447 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0013 events2 affected447 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0011 events1 affected447 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0011 events1 affected447 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected433 at risk EG0010 events0 affected447 at risk
Cardiac pacemaker battery replacement	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Hypotension	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Pelvic venous thrombosis	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected433 at risk EG0011 events1 affected447 at risk
Superior vena caval occlusion	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected433 at risk EG0012 events2 affected447 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Thrombosis	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk
Vascular insufficiency	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected433 at risk EG0010 events0 affected447 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG000175 events135 affected433 at risk EG001200 events155 affected447 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG00067 events33 affected433 at risk EG001179 events86 affected447 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG000141 events82 affected433 at risk EG001524 events252 affected447 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG000117 events61 affected433 at risk EG001151 events94 affected447 at risk
Coronary artery disease	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00023 events23 affected433 at risk EG00124 events24 affected447 at risk
Hypothyroidism	Endocrine disorders	MedDRA 11.0	Systematic Assessment	EG00026 events26 affected433 at risk EG00112 events12 affected447 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00026 events24 affected433 at risk EG00127 events27 affected447 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG000165 events135 affected433 at risk EG001155 events124 affected447 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00072 events62 affected433 at risk EG00169 events59 affected447 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00024 events24 affected433 at risk EG00126 events24 affected447 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00028 events28 affected433 at risk EG00121 events21 affected447 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG000261 events166 affected433 at risk EG001267 events159 affected447 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00023 events22 affected433 at risk EG00119 events15 affected447 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00096 events71 affected433 at risk EG001106 events72 affected447 at risk
Asthenia	General disorders	MedDRA 11.0	Systematic Assessment	EG00055 events48 affected433 at risk EG00151 events43 affected447 at risk
Chest pain	General disorders	MedDRA 11.0	Systematic Assessment	EG000104 events98 affected433 at risk EG001127 events114 affected447 at risk
Fatigue	General disorders	MedDRA 11.0	Systematic Assessment	EG000177 events153 affected433 at risk EG001221 events182 affected447 at risk
Mucosal inflammation	General disorders	MedDRA 11.0	Systematic Assessment	EG00026 events22 affected433 at risk EG00133 events26 affected447 at risk
Oedema peripheral	General disorders	MedDRA 11.0	Systematic Assessment	EG00040 events38 affected433 at risk EG00141 events33 affected447 at risk
Pyrexia	General disorders	MedDRA 11.0	Systematic Assessment	EG00029 events26 affected433 at risk EG00159 events49 affected447 at risk
Haemoglobin decreased	Investigations	MedDRA 11.0	Systematic Assessment	EG00024 events22 affected433 at risk EG00115 events15 affected447 at risk
Weight decreased	Investigations	MedDRA 11.0	Systematic Assessment	EG00064 events60 affected433 at risk EG00153 events50 affected447 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG000130 events108 affected433 at risk EG001120 events98 affected447 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG00045 events45 affected433 at risk EG00144 events44 affected447 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG00045 events45 affected433 at risk EG00147 events47 affected447 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG00025 events23 affected433 at risk EG00126 events18 affected447 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG00024 events23 affected433 at risk EG00118 events17 affected447 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG00031 events25 affected433 at risk EG00137 events27 affected447 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00024 events23 affected433 at risk EG00143 events38 affected447 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00067 events61 affected433 at risk EG00191 events81 affected447 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00016 events15 affected433 at risk EG00126 events26 affected447 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00023 events23 affected433 at risk EG00133 events31 affected447 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00030 events29 affected433 at risk EG00118 events17 affected447 at risk
Dizziness	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00034 events30 affected433 at risk EG00143 events41 affected447 at risk
Headache	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00062 events49 affected433 at risk EG00178 events61 affected447 at risk
Anxiety	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG00045 events45 affected433 at risk EG00136 events36 affected447 at risk
Depression	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG00041 events41 affected433 at risk EG00138 events38 affected447 at risk
Insomnia	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG00078 events72 affected433 at risk EG00178 events68 affected447 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00069 events69 affected433 at risk EG00171 events71 affected447 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG000218 events210 affected433 at risk EG001239 events221 affected447 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00050 events49 affected433 at risk EG00143 events42 affected447 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG000189 events178 affected433 at risk EG001200 events182 affected447 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00034 events33 affected433 at risk EG00134 events32 affected447 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00031 events31 affected433 at risk EG00121 events20 affected447 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG00029 events27 affected433 at risk EG001158 events156 affected447 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG00024 events23 affected433 at risk EG00136 events25 affected447 at risk
Hypertension	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG000181 events180 affected433 at risk EG001175 events172 affected447 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 + Carboplatin	Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles (Participants who received at least one dose of study drug)			150		425
EG001	Etoposide + Carboplatin	Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles. (Participants who received at least one dose of study drug)			134		438

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
D011034	Podophyllotoxin
D013764	Tetrahydronaphthalenes
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds
D005960	Glucosides
D006027	Glycosides
D002241	Carbohydrates
D056831	Coordination Complexes

ID	Title	Description
BG000	Pemetrexed + Carboplatin	Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
BG001	Etoposide + Carboplatin	Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
BG002	Total	Total of all reporting groups