Chemotherapy in Treating Patients With Non-Small Cell Lun... | NCT00520676

ID	Type	Description	Link
H3E-CR-S380	Other Identifier	Eli Lilly and Company

Label	Type	Description	Intervention Names
pemetrexed plus carboplatin	Experimental	Drug: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous (IV), every (q) 21 days x 6 cycles maximum Drug: carboplatin Area Under the Curve (AUC) 5 milligramminute/milliLiter (mgmin/mL), IV, q 21 days x 6 cycles maximum	Drug: pemetrexed Drug: carboplatin
docetaxel plus carboplatin	Active Comparator	Drug: docetaxel 75 mg/m^2, IV, q 21 days x 6 cycles maximum Drug: carboplatin AUC 5 mg*min/mL, IV, q 21 days x 6 cycles maximum	Drug: docetaxel Drug: carboplatin

Name	Type	Description	Arm Group Labels	Other Names
pemetrexed	Drug	500 mg/m^2, IV, q 21 days x 6 cycles maximum	pemetrexed plus carboplatin

Measure	Description	Time Frame
Survival Without Grade 3 or 4 Toxicity	Defined as the time from date of randomization to first date of a Grade 3 or 4 treatment-emergent adverse event (TEAE; as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE], version 3.0) or death due to any cause. Grade 3 TEAE: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Grade 4 TEAE: Life-threatening consequences; urgent intervention indicated. Participants who were alive without experiencing Grade 3 or 4 toxicity were censored at the date of last contact.	Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).

Measure	Description	Time Frame
Overall Survival (OS)	OS is the duration from enrollment to death. For participants who are alive, OS is censored at the last contact.	Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).
Progression-free Survival (PFS)

Measure	Description	Time Frame
Duration of Response	The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=at least a 30% decrease 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.		Ballarat	Victoria	3350

PubMed Identifier	Type	Citation	Retractions
37922432	Derived	Loureiro H, Kolben TM, Kiermaier A, Ruttinger D, Ahmidi N, Becker T, Bauer-Mehren A. Correlation Between Early Trends of a Prognostic Biomarker and Overall Survival in Non-Small-Cell Lung Cancer Clinical Trials. JCO Clin Cancer Inform. 2023 Sep;7:e2300062. doi: 10.1200/CCI.23.00062.
24277116	Derived	Pereira JR, Cheng R, Orlando M, Kim JH, Barraclough H. Elderly subset analysis of randomized phase III study comparing pemetrexed plus carboplatin with docetaxel plus carboplatin as first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer. Drugs R D. 2013 Dec;13(4):289-96. doi: 10.1007/s40268-013-0032-6.

ID	Title	Description
FG000	Pemetrexed Plus Carboplatin	pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
FG001	Docetaxel Plus Carboplatin	docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days

ID	Title	Description
BG000	Pemetrexed Plus Carboplatin	pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
BG001	Docetaxel Plus Carboplatin	docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
BG002	Total	Total of all reporting groups

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

Survival Without Grade 3 or 4 Toxicity

Defined as the time from date of randomization to first date of a Grade 3 or 4 treatment-emergent adverse event (TEAE; as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE], version 3.0) or death due to any cause. Grade 3 TEAE: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Grade 4 TEAE: Life-threatening consequences; urgent intervention indicated.

Participants who were alive without experiencing Grade 3 or 4 toxicity were censored at the date of last contact.

Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.

Posted

Median

95% Confidence Interval

months

Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).

ID	Title	Description
OG000	Pemetrexed Plus Carboplatin	pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
OG001	Docetaxel Plus Carboplatin	docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days

Units	Counts
Participants	OG000106 OG001105

Title

Denominators

Categories

Title	Measurements
	OG0003.2(2.1 to 3.7) OG0010.7(0.5 to 1.2)

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	Note that the 2-sided p-value for log rank is reported, which is <0.001, hence 1-sided p-value is <0.001.	<0.001	The comparison was conducted at a 1-sided significance level of 0.05.	Hazard Ratio (HR)	0.45			2-Sided	95	0.34	0.60			Cox regression model is used for HR estimate.	No	Superiority or Other

Secondary

Overall Survival (OS)

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

Posted

Median

95% Confidence Interval

months

Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).

ID	Title	Description
OG000	Pemetrexed Plus Carboplatin	pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
OG001	Docetaxel Plus Carboplatin	docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days

Units	Counts
Participants	OG000

Secondary

Progression-free Survival (PFS)

Defined as the time from date of first dose to the first observation of disease progression (PD), or death due to any cause.

Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This set includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.

Posted

Median

95% Confidence Interval

months

Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).

ID	Title	Description
OG000	Pemetrexed Plus Carboplatin	pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
OG001	Docetaxel Plus Carboplatin	docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Tumor Response (Response Rate)

Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes not meeting above criteria. Response rate (%)=Number of participants with CR+PR/Number of participants analyzed *100. Disease Control rate=Number of participants with SD+PR+CR/Number of participants analyzed *100.

Analysis was performed on tumour response-qualified population. This population includes all participants with locally advanced or metastatic non-small cell lung cancer (NSCLC), non-squamous histology with measurable disease as defined by RECIST (Version 1.0), who received at least 1 dose of pemetrexed, docetaxel, or carboplatin.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).

ID	Title	Description
OG000	Pemetrexed Plus Carboplatin	pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
OG001	Docetaxel Plus Carboplatin	docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days

Other Pre-specified

Duration of Response

The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=at least a 30% decrease in sum of longest diameter of target lesions.

Analysis was performed on tumour response qualified population. This population includes all participants with locally advanced or metastatic non-small cell lung cancer (NSCLC), non-squamous histology with measurable disease as defined by RECIST (Version 1.0), who received at least 1 dose of pemetrexed, docetaxel, or carboplatin.

Posted

Median

95% Confidence Interval

months

Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).

ID	Title	Description
OG000	Pemetrexed Plus Carboplatin	pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
OG001	Docetaxel Plus Carboplatin	docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days

Units	Counts

Secondary

Survival Without Clinically Important Grade 3 or 4 Toxicity

Survival without Grade 3 or 4 toxicity is the time from date of randomization to the first date of the following clinically important Grade 3 or 4 TEAEs graded by the Common Terminology Criteria for Adverse Events [CTCAE], version 3.0: neutropenia (lasting >5 days), febrile neutropenia, documented infections related to neutropenia, anemia, thrombocytopenia, fatigue, nausea, vomiting, diarrhea, stomatitis, and neurosensory events; or death due to any cause. Participants who were alive without experiencing Grade 3 or 4 toxicity were censored for this analysis at the date of last contact.

Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least one dose of the study drug according to the treatment the participants were assigned.

Posted

Median

95% Confidence Interval

months

Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).

ID	Title	Description
OG000	Pemetrexed Plus Carboplatin	pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
OG001	Docetaxel Plus Carboplatin	docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days

Secondary

Survival Without Grade 4 Toxicity

Survival without Grade 4 toxicity is the time from the date of randomization to the first date of a Grade 4 TEAE or death due to any cause. Participants who are alive without experiencing Grade 4 toxicity will be censored for this analysis at the date of last contact.

Posted

Median

95% Confidence Interval

participants

Baseline to until 218 events (defined as death or Grade 4 toxicity) have been observed (up to 33.3 months).

ID	Title	Description
OG000	Pemetrexed Plus Carboplatin	pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
OG001	Docetaxel Plus Carboplatin	docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days

Units	Counts
Participants

Secondary

Number of Participants With Adverse Events (AEs)

Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.

Analysis was performed on safety population. This population includes all participants with non-squamous histology who received at least one dose of study drug. Participants were analysed according to treatments they actually received.

Posted

Number

participants

Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).

ID	Title	Description
OG000	Pemetrexed Plus Carboplatin	pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
OG001	Docetaxel Plus Carboplatin	docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected105 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected106 at risk EG00110 events9 affected105 at risk
Haematotoxicity	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected105 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0013 events3 affected105 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0019 events8 affected105 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected105 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0003 events3 affected106 at risk EG0012 events2 affected105 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected105 at risk
Arrhythmia	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0011 events1 affected105 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0013 events3 affected105 at risk
Cardiac arrest	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected105 at risk
Cor pulmonale	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected105 at risk
Tachycardia	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected105 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected105 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0013 events3 affected105 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected105 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected105 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0012 events2 affected105 at risk
Asthenia	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0012 events2 affected105 at risk
Chest pain	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected105 at risk
Death	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected105 at risk
Pain	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected105 at risk
Pyrexia	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0012 events2 affected105 at risk
Anaphylactic shock	Immune system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected105 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected105 at risk
Device related infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected105 at risk
Pharyngitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected105 at risk
Pneumonia	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0005 events5 affected106 at risk EG0017 events7 affected105 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected105 at risk
Septic shock	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0011 events1 affected105 at risk
Body temperature increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected105 at risk
Platelet count decreased	Investigations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected105 at risk
Troponin increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected105 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected105 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected105 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected105 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected105 at risk
Convulsion	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected105 at risk
Neuralgia	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected105 at risk
Anxiety	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected105 at risk
Renal failure	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0011 events1 affected105 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected105 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0011 events1 affected105 at risk
Asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected105 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected105 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0013 events3 affected105 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0011 events1 affected105 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected105 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected105 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0011 events1 affected105 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0013 events3 affected105 at risk
Arterial occlusive disease	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected105 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected105 at risk
Hypotension	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected105 at risk
Superior vena caval occlusion	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0011 events1 affected105 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG00046 events36 affected106 at risk EG00125 events18 affected105 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG00080 events33 affected106 at risk EG001139 events56 affected105 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG00026 events14 affected106 at risk EG00138 events25 affected105 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG000109 events40 affected106 at risk EG001203 events74 affected105 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG00023 events12 affected106 at risk EG0016 events4 affected105 at risk
Arrhythmia	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0003 events3 affected106 at risk EG0016 events6 affected105 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00014 events11 affected106 at risk EG00116 events13 affected105 at risk
Constipation	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00023 events18 affected106 at risk EG00117 events15 affected105 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00021 events12 affected106 at risk EG00143 events30 affected105 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0006 events5 affected106 at risk EG0018 events7 affected105 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00071 events43 affected106 at risk EG00166 events37 affected105 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00017 events9 affected106 at risk EG00116 events11 affected105 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00022 events18 affected106 at risk EG00131 events19 affected105 at risk
Asthenia	General disorders	MedDRA 13.0	Systematic Assessment	EG00020 events15 affected106 at risk EG00130 events19 affected105 at risk
Chest pain	General disorders	MedDRA 13.0	Systematic Assessment	EG0004 events4 affected106 at risk EG0017 events7 affected105 at risk
Fatigue	General disorders	MedDRA 13.0	Systematic Assessment	EG00015 events13 affected106 at risk EG00124 events21 affected105 at risk
Mucosal inflammation	General disorders	MedDRA 13.0	Systematic Assessment	EG00011 events7 affected106 at risk EG0017 events5 affected105 at risk
Oedema	General disorders	MedDRA 13.0	Systematic Assessment	EG0004 events4 affected106 at risk EG0016 events6 affected105 at risk
Pyrexia	General disorders	MedDRA 13.0	Systematic Assessment	EG00012 events11 affected106 at risk EG00115 events7 affected105 at risk
Conjunctivitis infective	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0008 events7 affected106 at risk EG0010 events0 affected105 at risk
Nail infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0017 events7 affected105 at risk
Alanine aminotransferase increased	Investigations	MedDRA 13.0	Systematic Assessment	EG00011 events9 affected106 at risk EG0013 events3 affected105 at risk
Platelet count decreased	Investigations	MedDRA 13.0	Systematic Assessment	EG00013 events7 affected106 at risk EG00111 events5 affected105 at risk
Weight decreased	Investigations	MedDRA 13.0	Systematic Assessment	EG0003 events3 affected106 at risk EG0016 events6 affected105 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG00037 events27 affected106 at risk EG00135 events30 affected105 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0004 events4 affected106 at risk EG0016 events6 affected105 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0003 events3 affected106 at risk EG00111 events8 affected105 at risk
Dizziness	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0008 events7 affected106 at risk EG0017 events7 affected105 at risk
Dysgeusia	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG00012 events7 affected106 at risk EG00115 events11 affected105 at risk
Headache	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0009 events8 affected106 at risk EG0019 events7 affected105 at risk
Neurotoxicity	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0002 events2 affected106 at risk EG00111 events7 affected105 at risk
Paraesthesia	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0018 events7 affected105 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG00010 events7 affected106 at risk EG00118 events14 affected105 at risk
Insomnia	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0007 events7 affected106 at risk EG0017 events6 affected105 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG00014 events13 affected106 at risk EG0018 events8 affected105 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG00010 events10 affected106 at risk EG00110 events10 affected105 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0009 events8 affected106 at risk EG0013 events2 affected105 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG00011 events10 affected106 at risk EG00146 events45 affected105 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0008 events7 affected106 at risk EG0015 events5 affected105 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0009 events8 affected106 at risk EG0019 events9 affected105 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
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D056831	Coordination Complexes

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pemetrexed Plus Carboplatin	pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days			28	106	94	106
EG001	Docetaxel Plus Carboplatin	docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days			35	105	100	105