A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients... | NCT02117024

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Viagenpumatucel-L Plus Metronomic Cyclophosphamide	Experimental	Viagenpumatucel-L (HS-110) given as 1*10^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks.	Drug: Viagenpumatucel-L Drug: Metronomic Cyclophosphamide
Chemotherapy Alone	Active Comparator	Patients will be treated with a physician's choice regimen until progression.	Drug: Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Viagenpumatucel-L	Drug	Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig	Viagenpumatucel-L Plus Metronomic Cyclophosphamide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	Overall survival (OS) calculated as the duration of survival from the date of randomization to the date of death from any cause, or was censored on the date the patient was last known to be alive. Survival time was calculated from the randomization date up to the date of death,or censored on the date that the patient was last known to be alive (last available visit date) utilizing Kaplan-Meier Estimate of Overall Survival Ending Events	Up to 3 years

Secondary Outcomes

Measure	Description	Time Frame
Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE)	Evaluate the safety of the combination of viagenpumatucel-L and low-dose cyclophosphamide by frequency of Treatment-Emergent Adverse Events	Up to 3 years
Disease Control Rate (DCR)

Eligibility Module

Name	Affiliation	Role
Roger Cohen, MD	University of Pennsylvania	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Highlands Oncology Group		Rogers	Arkansas	72758	United States
University of California San Diego

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Viagenpumatucel-L Plus Metronomic Cyclophosphamide	Viagenpumatucel-L (HS-110) given as 1*10^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks. Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 29, 2014

Arm/Group Information

ID	Title	Description
BG000	Viagenpumatucel-L Plus Metronomic Cyclophosphamide	Viagenpumatucel-L (HS-110) given as 1*10^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks. Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
BG001	Chemotherapy Alone	Patients will be treated with a physician's choice regimen until progression. Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice: Vinorelbine Erlotinib Gemcitabine Paclitaxel Docetaxel Pemetrexed
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00045 BG00121 BG00266

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00065.6± 8.9 BG00163.0± 10.5 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00027 BG00110 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00038 BG00118 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 (OS)

Overall survival (OS) calculated as the duration of survival from the date of randomization to the date of death from any cause, or was censored on the date the patient was last known to be alive.

Survival time was calculated from the randomization date up to the date of death,or censored on the date that the patient was last known to be alive (last available visit date) utilizing Kaplan-Meier Estimate of Overall Survival Ending Events

Posted

Median

95% Confidence Interval

Days

Up to 3 years

ID	Title	Description
OG000	Viagenpumatucel-L Plus Metronomic Cyclophosphamide	Viagenpumatucel-L (HS-110) given as 1*10^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks. Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
OG001	Chemotherapy Alone	Patients will be treated with a physician's choice regimen until progression. Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice: Vinorelbine Erlotinib Gemcitabine Paclitaxel Docetaxel Pemetrexed

Units	Counts
Participants	OG00045 OG00121

Title

Denominators

Categories

Title	Measurements
	OG000176(114.0 to 231.0) OG001372(204.0 to 875.0)

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		0.0011														Superiority
OG000 OG001	With only 50% of enrollment complete prior to study termination by sponsor, insufficient sample size exists to fully complete efficacy analysis.	Other

Secondary

Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE)

Evaluate the safety of the combination of viagenpumatucel-L and low-dose cyclophosphamide by frequency of Treatment-Emergent Adverse Events

Safety was defined as the number of adverse events (AE)/serious adverse events (SAE) in patients receiving viagenpumatucel-L and low-dose Cyclophosphamide (CY).

Posted

Count of Participants

Participants

Up to 3 years

ID	Title	Description
OG000	Viagenpumatucel-L Plus Metronomic Cyclophosphamide	Viagenpumatucel-L (HS-110) given as 1*10^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks. Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
OG001	Chemotherapy Alone	Patients will be treated with a physician's choice regimen until progression. Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice: Vinorelbine Erlotinib Gemcitabine Paclitaxel Docetaxel Pemetrexed

Secondary

Disease Control Rate (DCR)

Evaluate overall immune-related DCR (irDCR) and also DCR by Response Evaluation Criteria in Solid Tumors (RECIST) (complete response, partial response, and stable disease)

Data were not collected for Outcome Measure 3 due to study termination (50% enrollment) by the Sponsor on 01 September 2015 due to changing treatment landscape (PD-1 approvals), and a subsequent change in development focus to Immuno-Oncology (IO) combinations. See NCT02439450.

Posted

Up to 3 years

ID	Title	Description
OG000	Viagenpumatucel-L Plus Metronomic Cyclophosphamide	Viagenpumatucel-L (HS-110) given as 1*10^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks. Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
OG001	Chemotherapy Alone	Patients will be treated with a physician's choice regimen until progression. Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice: Vinorelbine Erlotinib Gemcitabine Paclitaxel Docetaxel Pemetrexed

Secondary

6-Month Disease Control Rate (6mDCR)

Evaluate 6-month immune-related DCR (6m-irDCR) and also 6mDCR by RECIST (complete response, partial response, and stable disease at 6 months following randomization)

Data were not collected for Outcome Measure 4 due to study termination (50% enrollment) by the Sponsor on 01 September 2015 due to changing treatment landscape (PD-1 approvals), and a subsequent change in development focus to Immuno-Oncology (IO) combinations. See NCT02439450.

Posted

6 months

ID	Title	Description
OG000	Viagenpumatucel-L Plus Metronomic Cyclophosphamide	Viagenpumatucel-L (HS-110) given as 1*10^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks. Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
OG001	Chemotherapy Alone	Patients will be treated with a physician's choice regimen until progression. Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice: Vinorelbine Erlotinib Gemcitabine Paclitaxel Docetaxel Pemetrexed

Secondary

Overall Response Rate (ORR)

Evaluate immune-related ORR (irORR) and also ORR by RECIST (complete response and partial response)

Data were not collected for Outcome Measure 5 due to study termination (50% enrollment) by the Sponsor on 01 September 2015 due to changing treatment landscape (PD-1 approvals), and a subsequent change in development focus to Immuno-Oncology (IO) combinations. See NCT02439450.

Posted

Up to 3 years

ID	Title	Description
OG000	Viagenpumatucel-L Plus Metronomic Cyclophosphamide	Viagenpumatucel-L (HS-110) given as 1*10^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks. Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
OG001	Chemotherapy Alone	Patients will be treated with a physician's choice regimen until progression. Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice: Vinorelbine Erlotinib Gemcitabine Paclitaxel Docetaxel Pemetrexed

Secondary

Progression-Free Survival (PFS)

Evaluate immune-related PFS (irPFS) and PFS by RECIST (Response Evaluation Criteria for Solid Tumors)

Calculated from randomization date to earliest date of first 'Progressive Disease' response (Immune-Related / RECIST Response Criteria) or date of death, and censored on the date of the last available post-baseline tumor assessment.

Posted

Median

95% Confidence Interval

Days

Up to 3 years

ID	Title	Description
OG000	Viagenpumatucel-L Plus Metronomic Cyclophosphamide	Viagenpumatucel-L (HS-110) given as 1*10^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks. Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
OG001	Chemotherapy Alone	Patients will be treated with a physician's choice regimen until progression. Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice: Vinorelbine Erlotinib Gemcitabine Paclitaxel Docetaxel Pemetrexed

Secondary

Time to Progression (TTP)

Evaluate immune-related TTP (irTTP) and also TTP (Time to Progression) by RECIST

Time to immune-related progression was calculated from the randomization date up to the date of the first 'Progressive Disease' response (Immune-Related Response Criteria) Time to progression was calculated from the randomization date up to the date of the first 'Progressive Disease' response (RECIST Response Criteria).

Posted

Median

95% Confidence Interval

Days

Up to 3 years

ID	Title	Description
OG000	Viagenpumatucel-L Plus Metronomic Cyclophosphamide	Viagenpumatucel-L (HS-110) given as 1*10^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks. Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
OG001	Chemotherapy Alone	Patients will be treated with a physician's choice regimen until progression. Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice: Vinorelbine Erlotinib Gemcitabine Paclitaxel Docetaxel Pemetrexed

Secondary

Survival at 6 Months

Evaluate the proportion of patients who are alive at 6 months following randomization

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	Viagenpumatucel-L Plus Metronomic Cyclophosphamide	Viagenpumatucel-L (HS-110) given as 1*10^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks. Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
OG001	Chemotherapy Alone	Patients will be treated with a physician's choice regimen until progression. Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice: Vinorelbine Erlotinib Gemcitabine Paclitaxel Docetaxel Pemetrexed

Units	Counts

Secondary

Survival at 12 Months

Evaluate the proportion of patients who are alive at 12 months following randomization

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Viagenpumatucel-L Plus Metronomic Cyclophosphamide	Viagenpumatucel-L (HS-110) given as 1*10^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks. Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
OG001	Chemotherapy Alone	Patients will be treated with a physician's choice regimen until progression. Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice: Vinorelbine Erlotinib Gemcitabine Paclitaxel Docetaxel Pemetrexed

Units	Counts

Secondary

Immune Response

Characterize the peripheral blood immunologic response via intracellular cytokine staining (ICS) by flow cytometry and/or enzyme-linked immunosorbent spot (ELISPOT) on cluster of differentiation 8 positive (CD8+) cells following vaccination

Data were not collected for Outcome Measure 10 due to study termination (50% enrollment) by the Sponsor on 01 September 2015 due to changing treatment landscape (PD-1 approvals), and a subsequent change in development focus to Immuno-Oncology (IO) combinations. See NCT02439450.

Posted

Up to 3 years

ID	Title	Description
OG000	Viagenpumatucel-L Plus Metronomic Cyclophosphamide	Viagenpumatucel-L (HS-110) given as 1*10^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks. Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
OG001	Chemotherapy Alone	Patients will be treated with a physician's choice regimen until progression. Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice: Vinorelbine Erlotinib Gemcitabine Paclitaxel Docetaxel Pemetrexed

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	Viagenpumatucel-L Plus Metronomic Cyclophosphamide	Viagenpumatucel-L (HS-110) given as 1*10^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks. Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks	7	43	17	43	19	43
EG001	Chemotherapy Alone	Patients will be treated with a physician's choice regimen until progression. Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice: Vinorelbine Erlotinib Gemcitabine Paclitaxel Docetaxel Pemetrexed	0	20	8	20	9	20

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA v16.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0012 events2 affected20 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA v16.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected20 at risk
Cardiac Arrest	Cardiac disorders	MedDRA v16.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected20 at risk
Inappropriate Antidiuretic Hormone Secretion	Endocrine disorders	medDRA v16.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected20 at risk
Abdominal Pain	Gastrointestinal disorders	medDRA v16.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected20 at risk
Ileus	Gastrointestinal disorders	medDRA v16.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected20 at risk
Oesophagitis Ulcerative	Gastrointestinal disorders	medDRA v16.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected20 at risk
Vomiting	Gastrointestinal disorders	medDRA v16.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0012 events2 affected20 at risk
Disease Progression	General disorders	medDRA v16.1	Systematic Assessment	EG0002 events2 affected43 at risk EG0010 events0 affected20 at risk
Pain	General disorders	medDRA v16.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected20 at risk
Oral Candidiasis	Infections and infestations	medDRA v16.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected20 at risk
Pneumonia	Infections and infestations	medDRA v16.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected20 at risk
Cervical Vertebral Fracture	Injury, poisoning and procedural complications	medDRA v16.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected20 at risk
Humerus Fracture	Injury, poisoning and procedural complications	medDRA v16.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected20 at risk
Dehydration	Metabolism and nutrition disorders	medDRA v16.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected20 at risk
Hyponatraemia	Metabolism and nutrition disorders	medDRA v16.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected20 at risk
Back Pain	Musculoskeletal and connective tissue disorders	medDRA v16.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected20 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	medDRA v16.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected20 at risk
Malignant Pleural Effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	medDRA v16.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected20 at risk
Cerebrovascular Accident	Nervous system disorders	medDRA v16.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected20 at risk
Mental Status Changes	Psychiatric disorders	medDRA v16.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected20 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	medDRA v16.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected20 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	medDRA v16.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected20 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	medDRA v16.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected20 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	medDRA v16.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected20 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	medDRA v16.1	Systematic Assessment	EG0002 events2 affected43 at risk EG0010 events0 affected20 at risk
Deep Vein Thrombosis	Vascular disorders	medDRA v16.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected20 at risk
Superior Vena Cava Syndrome	Vascular disorders	medDRA v16.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected20 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cough	Respiratory, thoracic and mediastinal disorders	medDRA v16.1	Systematic Assessment	EG0005 events5 affected43 at risk EG0015 events4 affected20 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	medDRA v16.1	Systematic Assessment	EG00015 events11 affected43 at risk EG0018 events7 affected20 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	medDRA v16.1	Systematic Assessment	EG0003 events3 affected43 at risk EG0010 events0 affected20 at risk
Interstitial Lung Disease	Respiratory, thoracic and mediastinal disorders	medDRA v16.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected20 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	medDRA v16.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected20 at risk
Pleuritic Pain	Respiratory, thoracic and mediastinal disorders	medDRA v16.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected20 at risk
Rhinorrhea	Respiratory, thoracic and mediastinal disorders	medDRA v16.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected20 at risk
Upper Respiratory Tract Congestion	Respiratory, thoracic and mediastinal disorders	medDRA v16.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected20 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	medDRA v16.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected20 at risk
Alopecia	Skin and subcutaneous tissue disorders	medDRA v16.1	Systematic Assessment	EG0002 events2 affected43 at risk EG0012 events2 affected20 at risk
Blister	Skin and subcutaneous tissue disorders	medDRA v16.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0012 events1 affected20 at risk
Eczema	Skin and subcutaneous tissue disorders	medDRA v16.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected20 at risk
Night Sweats	Skin and subcutaneous tissue disorders	medDRA v16.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0012 events2 affected20 at risk
Onychomadesis	Skin and subcutaneous tissue disorders	medDRA v16.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected20 at risk
Pruritis	Skin and subcutaneous tissue disorders	medDRA v16.1	Systematic Assessment	EG0003 events2 affected43 at risk EG0011 events1 affected20 at risk
Rash	Skin and subcutaneous tissue disorders	medDRA v16.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0012 events1 affected20 at risk
Deep Vein Thrombosis	Skin and subcutaneous tissue disorders	medDRA v16.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected20 at risk
Hot Flush	Skin and subcutaneous tissue disorders	medDRA v16.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0012 events2 affected20 at risk
Superior Vena Cava Syndrome	Skin and subcutaneous tissue disorders	medDRA v16.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected20 at risk

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

ID	Term
D014748	Vinca Alkaloids
D046948	Secologanin Tryptamine Alkaloids
D026121	Indole Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D054836	Indolizidines
D007212	Indolizines
D011799	Quinazolines
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D005971	Glutamates
D024342	Amino Acids, Acidic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000600	Amino Acids, Dicarboxylic

ID	Term
D000077235	Vinorelbine
D000069347	Erlotinib Hydrochloride
D000093542	Gemcitabine
D017239	Paclitaxel
D000077143	Docetaxel
D000068437	Pemetrexed