Chemotherapy and Radiation in Treating Participants With... | NCT00686959

NCT00686959

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

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A: Pemetrexed + Cisplatin and TRT	Experimental	Participants were treated with Pemetrexed plus Cisplatin and concurrent thoracic radiation therapy (TRT) ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 milligrams per meter squared (mg/m^2), intravenous (IV) on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gray [Gy] per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles	Drug: Pemetrexed Drug: Cisplatin Radiation: Thoracic Radiation Therapy (TRT)
Arm B: Etoposide + Cisplatin and TRT	Active Comparator	Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles Concurrent Phase: Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36 Consolidation Phase options: Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22	Drug: Cisplatin Drug: Etoposide Drug: Vinorelbine Drug: Paclitaxel Drug: Carboplatin Radiation: Thoracic Radiation Therapy (TRT)

Name	Type	Description	Arm Group Labels	Other Names
Pemetrexed	Drug	infusion over 10 minutes	Arm A: Pemetrexed + Cisplatin and TRT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival	Overall survival (OS) time is from baseline to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS time was censored at the last contact date the participant was known to be alive prior to the data cut-off date. OS was summarized using Kaplan-Meier estimates.	Baseline to Date of Death from Any Cause (Up to 71.4 Months)

Secondary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS)	Progression-free survival (PFS) time is from baseline to the first date of documented objective progressive disease (PD) or death from any cause. For participants who were not known to have died or to have had objective PD as of the data inclusion cut-off date for a particular analysis, PFS was censored at the date of the last objective progression-free disease assessments. For participants who took any subsequent systemic anticancer therapy prior to progression or death, PFS was censored at the date of the last objective progression-free disease assessment prior to the start date of any subsequent systemic anticancer therapy. PFS time was summarized using Kaplan-Meier estimates.

Other Outcomes

Measure	Description	Time Frame
Adverse Events: The Number of Deaths Per Treatment Group	The number of deaths that occurred while on study drug, the number of deaths due to adverse events (AEs) while on study drug, and the number of deaths due to the study disease (that is, disease progression) while on study drug are presented. In addition, the number of deaths within 30 days of treatment discontinuation, the number of deaths due to AEs within 30 days of treatment discontinuation, and the number of deaths due to study disease within 30 days of treatment discontinuation are presented. For both the deaths due to AEs that occurred on study and for deaths due to AEs that occurred within 30 days of treatment discontinuation, the causality (events assess as possibly related [poss related] to study drug per investigator judgement) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants must have Stage IIIA or IIIIB NSCLC of the non-squamous type
Participants must have measureable tumor lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated on computerized tomography (CT) scan
Participants must be physically mobile, take care of themselves and must be up and about and able to perform light activities, such as light housework or office work
Participants must be 18 years of age or older
Participants must have lost no more than 10% of their body weight in the previous 3 months
Women must be sterile, postmenopausal, or on contraception, and men must be sterile or on contraception
Participants' test results assessing the function of their blood forming tissue, kidneys, liver, and lungs must be satisfactory
Participants with Stage IIIB NSCLC who have supraclavicular nodal involvement may be entered into this study. However, participants with cervical nodes are not permitted. The upper border of supraclavicular nodes must not extend above the upper border of the lateral end of the clavicle, extended medially.

Exclusion Criteria:

Participants cannot have other on-going (uncontrolled) illnesses, including active infections, recent heart problems, or psychiatric illnesses
Participants who are unable to take vitamins (including injections of vitamin B12) or oral cortisone medication
Participants who have had a heart attack (myocardial infarction) or other cardiac issues within 6 months of the trial
Participants who have received other investigational drugs within the last 30 days
Participants who are unable to stop taking more than 1.3 grams of aspirin on a daily basis or non-steroidal anti-inflammatory agents
Participants who have diseases considered for surgical treatment as part of their care plan, such as Pancoast or superior sulcus tumors
Participants who had prior thoracic radiation. However, other prior radiotherapy is allowed. Participants must have recovered from the toxic effects of the treatment prior to study enrollment. Participants may not have received whole pelvis radiation or radiation to more than 25% of their bone marrow. Prior radiotherapy must have been completed at least 30 days prior to study treatment.
Participants who have a radiation treatment plan that would expose more than 35% of the volume of their lung to 20 gray (Gy) or more of radiation
Participants who have concurrent cancer from another primary site requiring treatment of any kind within the past 5 years. Exemptions to this will be permitted on a case-by-case basis after prior approval by the Sponsor physician or designate if the investigator believes the participant's risk of recurrence and death is very low. Curatively treated nonmelanoma skin cancer or in situ carcinoma of any origin is allowed. Participants with recurrence of a previously resected lung cancer or who have a second primary lung cancer are ineligible.

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.		Birmingham	Alabama	35249

PubMed Identifier	Type	Citation	Retractions
31125266	Derived	Govindan R, Senan S, Dickgreber N, Provencio M, Wu YL, Syrigos K, Parente B, Wilson M, Ziemiecki R, Chouaki N, Hossain A, San Antonio B, Winfree K, Vokes EE. Healthcare resource utilization and associated cost analysis of the PROCLAIM study in patients with stage III non-small-cell lung cancer. Curr Med Res Opin. 2019 Oct;35(10):1761-1767. doi: 10.1080/03007995.2019.1623185. Epub 2019 Jul 5.
29976505

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Arm A: Pemetrexed + Cisplatin and TRT	Participants were treated with Pemetrexed plus Cisplatin and concurrent thoracic radiation therapy (TRT) ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 milligrams per meter squared (mg/m^2), intravenous (IV) on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gray [Gy] per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Arm A: Pemetrexed + Cisplatin and TRT	Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles
BG001	Arm B: Etoposide + Cisplatin and TRT	Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles Concurrent Phase: Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36 Consolidation Phase options: Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00059.1± 9.6 BG00158.5± 9.4 BG00258.8± 9.5

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000124 BG001119 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

African

Title	Measurements
	BG00015 BG00112 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Argentina

Title	Measurements
	BG0002 BG0011 BG002

ECOG performance status

Eastern Cooperative Oncology Group (ECOG) performance status:

0=Fully active, able to carry on all pre-disease performance without restriction

1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, such as, light housework, office work

Number

participants

Title

Denominators

Categories

Title	Measurements
	BG000148 BG001

Disease stage

Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body). Stage IIIA - the cancer has spread to nearby tissue or spread to far away lymph nodes; Stage IIIB - cancer spread to opposite side of chest, more than one tumor within same lobe of lung.

Number

participants

Title

Denominators

Categories

Stage IIIA

Title	Measurements
	BG000140 BG001

Histology

Number

participants

Title

Denominators

Categories

Adenocarcinoma

Title	Measurements
	BG000226 BG001226 BG002

Smoking status

Number

participants

Title

Denominators

Categories

Never smoked

Title	Measurements
	BG00050 BG00158 BG002

Baseline PET scan

Participant had a baseline Positron Emission Tomography (PET) scan for staging

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG000250 BG001241 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Overall Survival

Overall survival (OS) time is from baseline to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS time was censored at the last contact date the participant was known to be alive prior to the data cut-off date. OS was summarized using Kaplan-Meier estimates.

All randomized participants. Arm A had 124 participants censored and Arm B had 117 participants censored.

Posted

Median

95% Confidence Interval

months

Baseline to Date of Death from Any Cause (Up to 71.4 Months)

ID	Title	Description
OG000	Arm A: Pemetrexed + Cisplatin and TRT	Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles
OG001	Arm B: Etoposide + Cisplatin and TRT	Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles Concurrent Phase: Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36 Consolidation Phase options: Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22

Units	Counts
Participants	OG000301 OG001297

Title

Denominators

Categories

Title	Measurements
	OG00026.81(20.40 to 30.92) OG00124.97(22.18 to 29.83)

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		0.831		Hazard Ratio (HR)	0.98			2-Sided	95	0.79	1.20				No	Superiority or Other

Secondary

Progression-free Survival (PFS)

Progression-free survival (PFS) time is from baseline to the first date of documented objective progressive disease (PD) or death from any cause. For participants who were not known to have died or to have had objective PD as of the data inclusion cut-off date for a particular analysis, PFS was censored at the date of the last objective progression-free disease assessments. For participants who took any subsequent systemic anticancer therapy prior to progression or death, PFS was censored at the date of the last objective progression-free disease assessment prior to the start date of any subsequent systemic anticancer therapy. PFS time was summarized using Kaplan-Meier estimates.

All randomized participants. Arm A had 99 participants censored and Arm B had 87 participants censored.

Posted

Median

95% Confidence Interval

months

Baseline to Measured Progressive Disease or Death from Any Cause (Up to 66.6 Months)

ID	Title	Description
OG000	Arm A: Pemetrexed + Cisplatin and TRT	Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles

Secondary

Objective Response Rate (Complete Response [CR] + Partial Response [PR])

Overall response rate (ORR) is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) guidelines. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.

All randomized participants.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline to Measured Progressive Disease (Up to 7 Months)

ID	Title	Description
OG000	Arm A: Pemetrexed + Cisplatin and TRT	Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles

Other Pre-specified

Adverse Events: The Number of Deaths Per Treatment Group

The number of deaths that occurred while on study drug, the number of deaths due to adverse events (AEs) while on study drug, and the number of deaths due to the study disease (that is, disease progression) while on study drug are presented. In addition, the number of deaths within 30 days of treatment discontinuation, the number of deaths due to AEs within 30 days of treatment discontinuation, and the number of deaths due to study disease within 30 days of treatment discontinuation are presented. For both the deaths due to AEs that occurred on study and for deaths due to AEs that occurred within 30 days of treatment discontinuation, the causality (events assess as possibly related [poss related] to study drug per investigator judgement) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

All randomized participants who received at least one dose of study drug.

Posted

Number

participants

Baseline through 30 Days Post Study

ID	Title	Description
OG000	Arm A: Pemetrexed + Cisplatin and TRT	Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles

Secondary

Survival Rates at 1, 2, and 3 Years

The probability that survival time is at least 1, 2, or 3 years was summarized using Kaplan-Meier estimates.

All randomized participants. Arm A had 124 participants censored and Arm B had 117 participants censored.

Posted

Number

95% Confidence Interval

probability of survival

Baseline to Date of Death from Any Cause (Up to 71.4 Months)

ID	Title	Description
OG000	Arm A: Pemetrexed + Cisplatin and TRT	Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles
OG001	Arm B: Etoposide + Cisplatin and TRT	Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles Concurrent Phase: Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36 Consolidation Phase options: Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22

Secondary

First Site of Disease Failure in Terms of Relapse

The percentage of participants with first sites of disease failure in terms of relapse within the radiation treatment field, inside the thorax, (outside of the radiation field), or distant disease are presented. Results were summarized using Kaplan-Meier estimates. Some participants relapsed in more than 1 location/site and appear in more than a single category.

All randomized participants with objective PD.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline to Relapse (Up to 66.6 Months)

ID	Title	Description
OG000	Arm A: Pemetrexed + Cisplatin and TRT	Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles
OG001	Arm B: Etoposide + Cisplatin and TRT	Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles Concurrent Phase: Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36 Consolidation Phase options: Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22

Secondary

Percentage of Participants With a Post Baseline Swallowing Diary Score >=4

Participants were provided with a swallowing diary to record issues with swallowing using a 5-point categorical scale: (1) no problems; (2) mild soreness; (3) swallowing solids with some difficulty; (4) inability to swallow solids; and (5) inability to swallow liquids. Participants rated swallowing over the previous 24 hours. The percentage of participants was calculated by dividing the number of with a post baseline swallowing diary score >=4 by total number of participants analyzed, multiplied by 100. No adjustments were made for the number of available assessments nor were any interpolation of missing assessments made.

All randomized participants with at least one post baseline swallowing diary score.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline through 30 Days Post Study

ID	Title	Description
OG000	Arm A: Pemetrexed + Cisplatin and TRT	Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm A:	Arm A: Participants were treated with pemetrexed plus cisplatin and concurrent thoracic radiation TRT ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for four 21-day cycles Concurrent Phase: Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles.			134	283	279	283
EG001	Arm B: Etoposide + Cisplatin and TRT	Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles Concurrent Phase: Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36 Consolidation Phase options: Option 1: Continue the same treatment plan as Concurrent Phase			145	272	269	272

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0006 events3 affected283 at risk EG00122 events5 affected272 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG00014 events12 affected283 at risk EG00125 events24 affected272 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0006 events4 affected283 at risk EG00112 events6 affected272 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG00111 events1 affected272 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG00021 events8 affected283 at risk EG00116 events13 affected272 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0012 events2 affected272 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0004 events1 affected283 at risk EG0017 events5 affected272 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG00011 events4 affected283 at risk EG0013 events3 affected272 at risk
Cardiac arrest	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0012 events2 affected272 at risk
Cardiac failure	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Coronary artery disease	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Endocarditis noninfective	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0012 events1 affected272 at risk
Myocardial infarction	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0003 events2 affected283 at risk EG0011 events1 affected272 at risk
Pericardial effusion	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Pericarditis	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected283 at risk EG0019 events1 affected272 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Aplasia	Congenital, familial and genetic disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Tracheo-oesophageal fistula	Congenital, familial and genetic disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0012 events1 affected272 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0015 events1 affected272 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG00111 events1 affected272 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Aorto-oesophageal fistula	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Constipation	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0003 events2 affected283 at risk EG0013 events2 affected272 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00015 events6 affected283 at risk EG0015 events5 affected272 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0011 events1 affected272 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0008 events4 affected283 at risk EG0017 events5 affected272 at risk
Enteritis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Eructation	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Gastritis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Gastrointestinal angiodysplasia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Gastrointestinal ulcer	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0007 events1 affected283 at risk EG0010 events0 affected272 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0011 events1 affected272 at risk
Ileus	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0012 events1 affected272 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00027 events8 affected283 at risk EG00114 events7 affected272 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG00116 events1 affected272 at risk
Oesophageal pain	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0012 events1 affected272 at risk
Oesophageal perforation	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00063 events26 affected283 at risk EG00189 events29 affected272 at risk
Oesophagitis ulcerative	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0012 events2 affected272 at risk
Vomiting	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00023 events14 affected283 at risk EG0019 events8 affected272 at risk
Asthenia	General disorders	MedDRA 17.1	Systematic Assessment	EG0004 events2 affected283 at risk EG0011 events1 affected272 at risk
Chest pain	General disorders	MedDRA 17.1	Systematic Assessment	EG0005 events3 affected283 at risk EG0015 events5 affected272 at risk
Death	General disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected283 at risk EG0010 events0 affected272 at risk
Fatigue	General disorders	MedDRA 17.1	Systematic Assessment	EG0004 events3 affected283 at risk EG0019 events4 affected272 at risk
Malaise	General disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected283 at risk EG0011 events1 affected272 at risk
Mucosal inflammation	General disorders	MedDRA 17.1	Systematic Assessment	EG0004 events1 affected283 at risk EG0011 events1 affected272 at risk
Multi-organ failure	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Non-cardiac chest pain	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG00110 events1 affected272 at risk
Pain	General disorders	MedDRA 17.1	Systematic Assessment	EG0002 events1 affected283 at risk EG0010 events0 affected272 at risk
Pyrexia	General disorders	MedDRA 17.1	Systematic Assessment	EG00014 events11 affected283 at risk EG0016 events4 affected272 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected283 at risk EG0010 events0 affected272 at risk
Atypical pneumonia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0012 events1 affected272 at risk
Bacteraemia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Bronchitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected283 at risk EG0010 events0 affected272 at risk
Bronchopneumonia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0012 events2 affected272 at risk
Device related infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected283 at risk EG0011 events1 affected272 at risk
Diverticulitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Gastroenteritis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0012 events2 affected272 at risk
Infectious colitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 events1 affected283 at risk EG0010 events0 affected272 at risk
Influenza	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Laryngitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0011 events1 affected272 at risk
Lobar pneumonia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0007 events1 affected283 at risk EG0012 events1 affected272 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0013 events3 affected272 at risk
Neutropenic infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Oral candidiasis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0004 events2 affected283 at risk EG0010 events0 affected272 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Pneumonia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG00030 events18 affected283 at risk EG00132 events18 affected272 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0013 events1 affected272 at risk
Pneumonia haemophilus	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Pneumonia necrotising	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 events1 affected283 at risk EG0010 events0 affected272 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Pseudomonas infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 events1 affected283 at risk EG0010 events0 affected272 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Respiratory tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0006 events4 affected283 at risk EG0012 events2 affected272 at risk
Sepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 events1 affected283 at risk EG0015 events4 affected272 at risk
Septic shock	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0011 events1 affected272 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0011 events1 affected272 at risk
Urinary tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0003 events2 affected283 at risk EG0012 events2 affected272 at risk
Varicella	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0006 events1 affected283 at risk EG0010 events0 affected272 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Radiation fibrosis - lung	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Radiation oesophagitis	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG00018 events7 affected283 at risk EG00120 events13 affected272 at risk
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG00019 events7 affected283 at risk EG00113 events5 affected272 at risk
Radiation skin injury	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0003 events1 affected283 at risk EG00114 events1 affected272 at risk
Stoma site pain	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Tracheal haemorrhage	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Blood creatinine increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0004 events2 affected283 at risk EG0010 events0 affected272 at risk
Haemoglobin decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0013 events1 affected272 at risk
Neutrophil count decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0012 events2 affected272 at risk
Platelet count decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0015 events3 affected272 at risk
Weight decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG00013 events4 affected283 at risk EG0011 events1 affected272 at risk
White blood cell count decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0012 events2 affected272 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0008 events3 affected283 at risk EG0013 events3 affected272 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00015 events7 affected283 at risk EG0018 events6 affected272 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0015 events3 affected272 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0012 events2 affected272 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0003 events2 affected283 at risk EG0011 events1 affected272 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0011 events1 affected272 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG00117 events1 affected272 at risk
Lung infiltration malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG00017 events3 affected283 at risk EG0010 events0 affected272 at risk
Paraneoplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0012 events1 affected272 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0004 events1 affected283 at risk EG0010 events0 affected272 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Cerebral infarction	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0002 events1 affected283 at risk EG00111 events1 affected272 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Convulsion	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Dizziness	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0003 events2 affected283 at risk EG0010 events0 affected272 at risk
Epilepsy	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Intracranial pressure increased	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Loss of consciousness	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0012 events1 affected272 at risk
Migraine	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Paraplegia	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0002 events1 affected283 at risk EG0010 events0 affected272 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Spinal cord compression	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0002 events1 affected283 at risk EG0010 events0 affected272 at risk
Syncope	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0011 events1 affected272 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0012 events2 affected272 at risk
Confusional state	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0004 events2 affected283 at risk EG0010 events0 affected272 at risk
Delirium	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Depression	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Hallucination	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Renal failure	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0007 events2 affected283 at risk EG0010 events0 affected272 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0003 events2 affected283 at risk EG0013 events3 affected272 at risk
Renal impairment	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0002 events1 affected283 at risk EG0010 events0 affected272 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 events1 affected283 at risk EG0011 events1 affected272 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Bronchial secretion retention	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 events1 affected283 at risk EG0010 events0 affected272 at risk
Bronchopleural fistula	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0013 events1 affected272 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0014 events1 affected272 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0004 events3 affected283 at risk EG00111 events3 affected272 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 events1 affected283 at risk EG00110 events2 affected272 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 events1 affected283 at risk EG0010 events0 affected272 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0006 events3 affected283 at risk EG0013 events2 affected272 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG00019 events6 affected283 at risk EG00119 events3 affected272 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0005 events3 affected283 at risk EG0010 events0 affected272 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG00010 events3 affected283 at risk EG00114 events10 affected272 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0011 events1 affected272 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0004 events3 affected283 at risk EG0011 events1 affected272 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG00115 events2 affected272 at risk
Embolism arterial	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Hypotension	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0011 events1 affected272 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected272 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected272 at risk
Phlebitis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0004 events1 affected283 at risk EG0010 events0 affected272 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0016 events2 affected272 at risk
Thrombophlebitis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0012 events1 affected272 at risk
Thrombosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0002 events1 affected283 at risk EG0011 events1 affected272 at risk
Vena cava thrombosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected283 at risk EG0015 events1 affected272 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG000336 events88 affected283 at risk EG001312 events94 affected272 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG000267 events63 affected283 at risk EG001237 events71 affected272 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG000297 events62 affected283 at risk EG001170 events47 affected272 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG000252 events92 affected283 at risk EG001359 events123 affected272 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG000116 events39 affected283 at risk EG001132 events53 affected272 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 17.1	Systematic Assessment	EG00040 events15 affected283 at risk EG00127 events8 affected272 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00094 events35 affected283 at risk EG00113 events8 affected272 at risk
Constipation	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG000312 events112 affected283 at risk EG001284 events129 affected272 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00088 events55 affected283 at risk EG001104 events63 affected272 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG000148 events43 affected283 at risk EG00195 events37 affected272 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG000567 events140 affected283 at risk EG001317 events110 affected272 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG000532 events175 affected283 at risk EG001365 events144 affected272 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG000103 events24 affected283 at risk EG00156 events23 affected272 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG000470 events119 affected283 at risk EG001253 events99 affected272 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00050 events26 affected283 at risk EG00123 events12 affected272 at risk
Vomiting	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG000244 events110 affected283 at risk EG001173 events95 affected272 at risk
Asthenia	General disorders	MedDRA 17.1	Systematic Assessment	EG000249 events64 affected283 at risk EG001101 events35 affected272 at risk
Chest pain	General disorders	MedDRA 17.1	Systematic Assessment	EG000154 events40 affected283 at risk EG00171 events32 affected272 at risk
Fatigue	General disorders	MedDRA 17.1	Systematic Assessment	EG000685 events139 affected283 at risk EG001472 events131 affected272 at risk
Mucosal inflammation	General disorders	MedDRA 17.1	Systematic Assessment	EG00073 events31 affected283 at risk EG00164 events23 affected272 at risk
Oedema peripheral	General disorders	MedDRA 17.1	Systematic Assessment	EG00061 events24 affected283 at risk EG00128 events12 affected272 at risk
Pyrexia	General disorders	MedDRA 17.1	Systematic Assessment	EG00076 events56 affected283 at risk EG00160 events42 affected272 at risk
Pneumonia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG00036 events17 affected283 at risk EG00121 events12 affected272 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG00029 events15 affected283 at risk EG00118 events11 affected272 at risk
Radiation oesophagitis	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG00050 events16 affected283 at risk EG00142 events18 affected272 at risk
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG00052 events22 affected283 at risk EG00129 events16 affected272 at risk
Radiation skin injury	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG000159 events45 affected283 at risk EG00181 events37 affected272 at risk
Alanine aminotransferase increased	Investigations	MedDRA 17.1	Systematic Assessment	EG00084 events21 affected283 at risk EG00125 events11 affected272 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 17.1	Systematic Assessment	EG00063 events20 affected283 at risk EG00118 events9 affected272 at risk
Blood creatinine increased	Investigations	MedDRA 17.1	Systematic Assessment	EG00067 events26 affected283 at risk EG00132 events16 affected272 at risk
Haemoglobin decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG000218 events48 affected283 at risk EG001155 events43 affected272 at risk
Neutrophil count decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG000115 events32 affected283 at risk EG00176 events31 affected272 at risk
Platelet count decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG00074 events24 affected283 at risk EG00178 events33 affected272 at risk
Weight decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG000257 events69 affected283 at risk EG001204 events61 affected272 at risk
White blood cell count decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG000212 events47 affected283 at risk EG001131 events43 affected272 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG000366 events104 affected283 at risk EG001228 events88 affected272 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00031 events19 affected283 at risk EG00138 events24 affected272 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00057 events16 affected283 at risk EG00125 events8 affected272 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00043 events20 affected283 at risk EG00149 events32 affected272 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00084 events22 affected283 at risk EG00184 events32 affected272 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00052 events19 affected283 at risk EG00155 events22 affected272 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG00033 events13 affected283 at risk EG00130 events17 affected272 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG00094 events26 affected283 at risk EG00151 events21 affected272 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG00041 events15 affected283 at risk EG00117 events11 affected272 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG00026 events11 affected283 at risk EG00130 events14 affected272 at risk
Dizziness	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG000152 events50 affected283 at risk EG00196 events45 affected272 at risk
Dysgeusia	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG000122 events31 affected283 at risk EG00160 events22 affected272 at risk
Headache	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG00092 events36 affected283 at risk EG00167 events34 affected272 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG00035 events14 affected283 at risk EG00164 events25 affected272 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG00080 events23 affected283 at risk EG00161 events21 affected272 at risk
Anxiety	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG00061 events17 affected283 at risk EG00135 events12 affected272 at risk
Insomnia	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG000175 events52 affected283 at risk EG001126 events42 affected272 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG000430 events105 affected283 at risk EG001273 events84 affected272 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG000308 events93 affected283 at risk EG001142 events53 affected272 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG00084 events31 affected283 at risk EG00133 events17 affected272 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG00043 events17 affected283 at risk EG00141 events24 affected272 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG00059 events23 affected283 at risk EG00123 events8 affected272 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG000110 events24 affected283 at risk EG001389 events103 affected272 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG00052 events12 affected283 at risk EG00143 events15 affected272 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG00050 events17 affected283 at risk EG00129 events13 affected272 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG00055 events18 affected283 at risk EG00119 events11 affected272 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG000110 events45 affected283 at risk EG00193 events40 affected272 at risk
Hypotension	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0006 events3 affected283 at risk EG00140 events16 affected272 at risk

Ancestor Terms

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
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
D014748	Vinca Alkaloids
D046948	Secologanin Tryptamine Alkaloids
D026121	Indole Alkaloids
D000470	Alkaloids
D007211	Indoles
D054836	Indolizidines
D007212	Indolizines
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D004224	Diterpenes
D013729	Terpenes
D056831	Coordination Complexes

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
D000068437	Pemetrexed
D002945	Cisplatin
D005047	Etoposide
D000077235	Vinorelbine
D017239	Paclitaxel
D016190	Carboplatin