A Study of Participant Reported Preference for Subcutaneo... | NCT06099782

ID	Type	Description
2023-506017-22-00	Registry Identifier	EU CT
U1111-1293-0814	Registry Identifier	UTN
MK-3475A-F11	Other Identifier	MSD
jRCT2051230147	Registry Identifier	Japan Registry of Clinical Trials (jRCT)

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A: Pembrolizumab (+) Berahyaluronidase alfa SC →Pembrolizumab IV	Experimental	In the Treatment Crossover Period: participants will first receive pembrolizumab (+) berahyaluronidase alfa SC for three 21-day cycles, followed by pembrolizumab IV for three 21-day cycles. After completion of the Treatment Crossover Period, participants will enter the Treatment Continuation Period where they will receive their preferred intervention for up to 17 21-day cycles (up to ~1 year) for renal cell carcinoma (RCC) and melanoma, and for up to 35 21-day cycles (up to ~2 years) for non-small cell lung cancer (NSCLC).	Biological: Pembrolizumab (+) Berahyaluronidase alfa Biological: Pembrolizumab
Arm B: Pembrolizumab IV→pembrolizumab (+) berahyaluronidase alfa SC	Active Comparator	In the Treatment Crossover Period: participants will first receive pembrolizumab IV for three 21-day cycles, followed by pembrolizumab (+) berahyaluronidase alfa SC for three 21-day cycles. After completion of the Treatment Crossover Period, participants will enter the Treatment Continuation Period where they will receive their preferred intervention for up to 17 21-day cycles (up to ~1 year) for renal cell carcinoma (RCC) and melanoma, and for up to 35 21-day cycles (up to ~2 years) for non-small cell lung cancer (NSCLC).	Biological: Pembrolizumab (+) Berahyaluronidase alfa Biological: Pembrolizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pembrolizumab (+) Berahyaluronidase alfa	Biological	Fixed dose coformulated product of hyaluronidase/pembrolizumab adminstered via SC injection.	Arm A: Pembrolizumab (+) Berahyaluronidase alfa SC →Pembrolizumab IV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Prefer Pembrolizumab Plus Berahyaluronidase Alfa Subcutaneous (SC) As Assessed By Patient Preference Questionnaire (PPQ) Question 1	The PPQ is an instrument that has been developed from participant interviews and includes questions to evaluate directly from participants their preference regarding mode of administration, as well as the strength of the preference, and the reason for the preference. The PPQ does not have any pre-defined scale or associated numerical scoring and answer choices are qualitative. Question 1 in the PPQ evaluates participants' preferred method of administration with response options of IV, SC or "no preference". As pre-specified by the protocol, the percentage of participants who preferred SC administration (participant preference rate [PPR]) was reported out of all randomized participants who received all 3 doses of Pembrolizumab IV and Pembrolizumab SC during treatment crossover period and answered at least question 1 of the PPQ on Cycle 6 Day 1 (Day 106).	Day 106

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Preferred SC Administration According to Most Frequent Reasons of Preference As Assessed by PPQ Question 3	The PPQ is an instrument that has been developed from patient interviews and includes questions to evaluate directly from participants their preference regarding mode of administration, as well as the strength of the preference, and the reason for the preference. PPQ Question 3 evaluated 2 main reasons for participants' preference for one of the administration methods (SC or IV), with response options including "feels less emotionally distressing", "requires less time in the clinic", and "lower level injection-site pain". As pre-specified by the supplemental statistical analysis plan (sSAP), the most frequent reasons for preferring SC administration as assessed by PPQ Question 3 were reported among all participants preferring SC in each treatment arm. Treatment arms A (Pembrolizumab Plus Berahyaluronidase alfa SC followed by Pembrolizumab IV) and B (Pembrolizumab IV followed by Pembrolizumab plus Berahyaluronidase alfa SC) were defined as treatment sequence arms in the protocol.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Has a histologically- or cytologically-confirmed early stage or advanced/ metastatic solid tumor by pathology report and meet the following conditions based on tumor type:
- Surgically resected Stage IIB and IIC (pathological or clinical), or III cutaneous melanoma per American Joint Committee on Cancer (AJCC) eighth edition.
- Surgically resected renal cell carcinoma (RCC) with intermediate-high or high risk of recurrence as defined by the Fuhrman grading status.
- Stage IV non-small cell lung cancer (NSCLC) per AJCC eight edition, with an anti-programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50% determined using the Dako PD-L1 immunohistochemistry (IHC) 22C3 pharmDx diagnostic kit, and confirmation that epidermal growth factor receptor (EGFR-), anaplastic lymphoma kinase (ALK-), or c-ros oncogene 1 (ROS1)- directed therapy is not indicated as primary therapy.
Has a life expectancy of at least 3 months.
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before randomization.
Participants with history of hepatitis C virus (HCV) infection are eligible if have completed curative antiviral therapy at least 4 weeks before randomization and HCV viral load is undetectable at screening.
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 3 days before the start of study intervention.

Exclusion Criteria:

Non-small cell lung cancer (NSCLC) participants with a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
Melanoma participants with ocular, mucosal, or conjunctival melanoma.
Renal Cell Carcinoma (RCC) participants who have had major surgery, other than nephrectomy, within 12 weeks before randomization.
Has received prior radiotherapy for RCC.
RCC participants who have residual thrombus post nephrectomy in the vena renalis or vena cava.
Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).
Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids.
Received prior systemic anticancer therapy for their metastatic NSCLC. Note: Prior treatment with neoadjuvant or adjuvant therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
Received radiation therapy to the lung that is >30 Gray within 6 months of start of study intervention.
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication.
Has known additional malignancy that is progressing or has required active treatment within the past 3 years.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has active autoimmune disease that has required systemic treatment in the past 2 years.
Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Has active infection requiring systemic therapy.
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
Has history of allogeneic tissue/solid organ transplant corticosteroids.
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Has not adequately recovered from major surgery or have ongoing surgical complications.

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Russell Medical ( Site 0160)		Alexander City	Alabama	35010	United States
Alaska Oncology and Hematology ( Site 0121)

PubMed Identifier	Type	Citation	Retractions
42234938	Derived	Casarini IA, Kowalski DM, Caglevic C, Karaca Yayla B, Sumbul AT, Yanez Weber P, Yanzi Castilla AN, Bylicki O, Takagi T, McQuarrie K, Saraf S, Arunachalam A, Bhagwati N, Cohen G. Participant-Reported Preference for Pembrolizumab Administered Subcutaneously or Intravenously: A Randomized, Open-Label, Phase II Study. JCO Oncol Pract. 2026 Jun 3:OP2501248. doi: 10.1200/OP-25-01248. Online ahead of print.

Label	URL
Merck Clinical Trials Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Arm A: Pembrolizumab (+) Berahyaluronidase Alfa SC →Pembrolizumab IV	In Treatment Crossover Period 1 participants first received pembrolizumab plus berahyaluronidase alfa subcutaneously (SC) for three 21-day cycles, followed by pembrolizumab intravenously (IV) for three 21-day cycles in Treatment Crossover Period 2. After completion of the Treatment Crossover Period, participants entered the Treatment Continuation Period where they received their preferred intervention for up to 17 21-day cycles (up to ~1 year) for renal cell carcinoma (RCC) and melanoma, and for up to 35 21-day cycles (up to ~2 years) for non-small cell lung cancer (NSCLC).

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	Yes	No	No	Study Protocol	Feb 5, 2024	Mar 20, 2026

Arm/Group Information

ID	Title	Description
BG000	Arm A: Pembrolizumab (+) Berahyaluronidase Alfa SC →Pembrolizumab IV	In Treatment Crossover Period 1 participants first received pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles, followed by pembrolizumab IV for three 21-day cycles in Treatment Crossover Period 2. After completion of the Treatment Crossover Period, participants entered the Treatment Continuation Period where they received their preferred intervention for up to 17 21-day cycles (up to ~1 year) for RCC and melanoma, and for up to 35 21-day cycles (up to ~2 years) for NSCLC.
BG001	Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC	In Treatment Crossover Period 1 participants first received pembrolizumab IV for three 21-day cycles, followed by pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles in Treatment Crossover Period 2. After completion of the Treatment Crossover Period, participants entered the Treatment Continuation Period where they received their preferred intervention for up to 17 21-day cycles (up to ~1 year) for RCC and melanoma, and for up to 35 21-day cycles (up to ~2 years) for NSCLC.
BG002	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Who Prefer Pembrolizumab Plus Berahyaluronidase Alfa Subcutaneous (SC) As Assessed By Patient Preference Questionnaire (PPQ) Question 1

The PPQ is an instrument that has been developed from participant interviews and includes questions to evaluate directly from participants their preference regarding mode of administration, as well as the strength of the preference, and the reason for the preference. The PPQ does not have any pre-defined scale or associated numerical scoring and answer choices are qualitative. Question 1 in the PPQ evaluates participants' preferred method of administration with response options of IV, SC or "no preference". As pre-specified by the protocol, the percentage of participants who preferred SC administration (participant preference rate [PPR]) was reported out of all randomized participants who received all 3 doses of Pembrolizumab IV and Pembrolizumab SC during treatment crossover period and answered at least question 1 of the PPQ on Cycle 6 Day 1 (Day 106).

Per protocol, the analysis population (Full Analysis Set) included all randomized participants who received all three doses of pembrolizumab plus berahyaluronidase alfa SC and all three doses of pembrolizumab IV during the Treatment Crossover Period, and subsequently answered question 1 of the PPQ on Day 106.

Posted

Number

Percentage of Participants

Day 106

ID	Title	Description
OG000	Full Analysis Set	Randomized participants received three doses of pembrolizumab plus berahyaluronidase alfa SC and three doses of pembrolizumab IV during the Treatment Crossover Period and subsequently answered question 1 of the PPQ on Day 106.

Units	Counts
Participants	OG000118

Title

Denominators

Categories

Title	Measurements
	OG00065.3

Secondary

Percentage of Participants Who Preferred SC Administration According to Most Frequent Reasons of Preference As Assessed by PPQ Question 3

The PPQ is an instrument that has been developed from patient interviews and includes questions to evaluate directly from participants their preference regarding mode of administration, as well as the strength of the preference, and the reason for the preference. PPQ Question 3 evaluated 2 main reasons for participants' preference for one of the administration methods (SC or IV), with response options including "feels less emotionally distressing", "requires less time in the clinic", and "lower level injection-site pain". As pre-specified by the supplemental statistical analysis plan (sSAP), the most frequent reasons for preferring SC administration as assessed by PPQ Question 3 were reported among all participants preferring SC in each treatment arm. Treatment arms A (Pembrolizumab Plus Berahyaluronidase alfa SC followed by Pembrolizumab IV) and B (Pembrolizumab IV followed by Pembrolizumab plus Berahyaluronidase alfa SC) were defined as treatment sequence arms in the protocol.

The analysis population included all randomized participants who received all three doses of pembrolizumab plus berahyaluronidase alfa SC and all three doses of pembrolizumab IV during the treatment crossover period, subsequently answered question 3 of the PPQ on Day 106, and preferred SC administration.

Posted

Number

Percentage of Participants

Day 106

ID	Title	Description
OG000	Arm A: Pembrolizumab (+) Berahyaluronidase Alfa SC →Pembrolizumab IV	In the Treatment Crossover Period participants first received pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles, followed by pembrolizumab IV for three 21-day cycles.

Secondary

Percentage of Participants That Were Satisfied or Dissatisfied With the SC Method of Administration According to Level of Satisfaction, As Assessed by Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) Question 1

The TASQ SC is a 12-item questionnaire that asks questions regarding different aspects of participants' satisfaction with SC administration, experiences related to administration, convenience, and time. The TASQ SC does not have any pre-defined scale or associated numerical scoring and answer choices are qualitative. Question 1 in the TASQ SC evaluates participants' satisfaction or dissatisfaction with SC administration. As pre-specified by the sSAP, the percentage of participants was reported for each response to TASQ-SC Question 1 according to level of satisfaction, for each treatment arm. Treatment arms A (Pembrolizumab Plus Berahyaluronidase alfa SC followed by Pembrolizumab IV) and B (Pembrolizumab IV followed by Pembrolizumab plus Berahyaluronidase alfa SC) were defined as treatment sequence arms in the protocol.

The analysis population included all randomized participants who received all three doses of pembrolizumab plus berahyaluronidase alfa SC and all three doses of pembrolizumab IV during the treatment crossover period, and subsequently answered question 1 of the TASQ SC.

Posted

Number

Percentage of Participants

Up to approximately Day 106

ID	Title	Description
OG000	Arm A: Pembrolizumab (+) Berahyaluronidase Alfa SC →Pembrolizumab IV	In the Treatment Crossover Period participants first received pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles, followed by pembrolizumab IV for three 21-day cycles.

Secondary

Percentage of Participants That Were Satisfied or Dissatisfied With the IV Method of Administration According to Level of Satisfaction, As Assessed by Therapy Administration Satisfaction Questionnaire -Intravenous (TASQ-IV) Question 1

The TASQ IV is a 12-item questionnaire that asks questions regarding different aspects of participants' satisfaction with IV administration, experiences related to administration, convenience, and time. The TASQ IV does not have any pre-defined scale or associated numerical scoring and answer choices are qualitative. Question 1 in the TASQ IV evaluates participants' satisfaction or dissatisfaction with IV administration. As pre-specified by the sSAP, the percentage of participants was reported for each response to TASQ-IV Question 1 according to level of satisfaction, for each treatment arm. Treatment arms A (Pembrolizumab Plus Berahyaluronidase alfa SC followed by Pembrolizumab IV) and B (Pembrolizumab IV followed by Pembrolizumab plus Berahyaluronidase alfa SC) were defined as treatment sequence arms in the protocol.

The analysis population included all randomized participants who received all three doses of pembrolizumab plus berahyaluronidase alfa SC and all three doses of pembrolizumab IV during the treatment crossover period, and subsequently answered question 1 of the TASQ IV.

Posted

Number

Percentage of Participants

Up to approximately Day 106

ID	Title	Description
OG000	Arm A: Pembrolizumab (+) Berahyaluronidase Alfa SC →Pembrolizumab IV	In the Treatment Crossover Period participants first received pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles, followed by pembrolizumab IV for three 21-day cycles.

Secondary

Percentage of Participants Who Chose Pembrolizumab (+) Berahyaluronidase Alfa SC or Pembrolizumab IV for the Treatment Continuation Period on the Participant Choice Questionnaire

The Participant Choice Questionnaire offered participants SC or IV treatment administration choices for the Treatment Continuation Period of the study, and was administered on Day 106 after study intervention administration. As pre-specified by the sSAP, the percentage of participants who chose either SC or IV treatment for the Treatment Continuation Period in the study was reported out of all randomized participants who chose to receive treatment intervention in the Treatment Continuation Period.

The analysis population included all randomized participants who chose to receive treatment intervention in the Treatment Continuation Period via the Participant Choice Questionnaire. Six participants included in the analysis chose to receive treatment in the Treatment Continuation Period but discontinued before receiving actual treatment.

Posted

Number

Percentage of Participants

Day 106

ID	Title	Description
OG000	Participants Continuing Treatment in Continuation Period	Randomized participants received three doses of pembrolizumab plus berahyaluronidase alfa SC and three doses of pembrolizumab IV during the Treatment Crossover Period and subsequently chose to receive treatment in the Treatment Continuation Period via the Participant Choice Questionnaire.

Units

Secondary

Number of Participants Who Experience an Adverse Event (AE)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. As pre-specified by the protocol, the number of participants who experience an AE will be reported for the overall study according to treatment arm, defined as a treatment sequence arm in the protocol (i.e., "Pembrolizumab Plus Berahyaluronidase alfa SC followed by Pembrolizumab IV" and "Pembrolizumab IV followed by Pembrolizumab plus Berahyaluronidase alfa SC").

Not Posted

Up to ~27 months

Participants

Secondary

Number of Participants Who Discontinue Study Drug Due to an AE

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. As pre-specified by the protocol, the number of participants who discontinue study drug due to an AE will be reported for the overall study according to treatment arm, defined as a treatment sequence arm in the protocol (i.e., "Pembrolizumab Plus Berahyaluronidase alfa SC followed by Pembrolizumab IV" and "Pembrolizumab IV followed by Pembrolizumab plus Berahyaluronidase alfa SC").

Not Posted

Up to ~24 months

Participants

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	Pembrolizumab (+) Berahyaluronidase Alfa SC	In Treatment Crossover Period 1 participants first received pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles, followed by pembrolizumab IV for three 21-day cycles in Treatment Crossover Period 2. After completion of the Treatment Crossover Period, participants entered the Treatment Continuation Period where they received their preferred intervention for up to 17 21-day cycles (up to ~1 year) for RCC and melanoma, and for up to 35 21-day cycles (up to ~2 years) for NSCLC.	10	141	20	141	99	141
EG001	Pembrolizumab IV	In Treatment Crossover Period 1 participants first received pembrolizumab IV for three 21-day cycles, followed by pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles in Treatment Crossover Period 2. After completion of the Treatment Crossover Period, participants entered the Treatment Continuation Period where they received their preferred intervention for up to 17 21-day cycles (up to ~1 year) for RCC and melanoma, and for up to 35 21-day cycles (up to ~2 years) for NSCLC.	6	141	22	141	63	141

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected141 at risk
Myocardial infarction	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected141 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected141 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected141 at risk
Hypophysitis	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected141 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected141 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected141 at risk
Gastritis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected141 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected141 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected141 at risk
Asthenia	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected141 at risk
Death	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected141 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected141 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected141 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected141 at risk
Abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected141 at risk
Diverticulitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected141 at risk
Empyema	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected141 at risk
Pneumonia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected141 at risk EG0014 events4 affected141 at risk
Urinary tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected141 at risk
Urosepsis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected141 at risk
Lipase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected141 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected141 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected141 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected141 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected141 at risk
Facet joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected141 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected141 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0006 events6 affected141 at risk EG0013 events3 affected141 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected141 at risk
Myasthenia gravis	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected141 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected141 at risk
Bipolar disorder	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected141 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected141 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected141 at risk
Malignant pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected141 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0012 events2 affected141 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected141 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0012 events2 affected141 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected141 at risk
Arteriosclerosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected141 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG00012 events10 affected141 at risk EG0018 events8 affected141 at risk
Hypothyroidism	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG00020 events20 affected141 at risk EG00116 events14 affected141 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00026 events21 affected141 at risk EG0018 events6 affected141 at risk
Asthenia	General disorders	MedDRA 27.1	Systematic Assessment	EG00014 events11 affected141 at risk EG0019 events7 affected141 at risk
Fatigue	General disorders	MedDRA 27.1	Systematic Assessment	EG00012 events12 affected141 at risk EG0018 events8 affected141 at risk
Injection site pain	General disorders	MedDRA 27.1	Systematic Assessment	EG00010 events10 affected141 at risk EG0010 events0 affected141 at risk
Injection site reaction	General disorders	MedDRA 27.1	Systematic Assessment	EG00015 events10 affected141 at risk EG0010 events0 affected141 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0008 events8 affected141 at risk EG0015 events5 affected141 at risk
Alanine aminotransferase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG00015 events11 affected141 at risk EG00116 events13 affected141 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG00013 events10 affected141 at risk EG00112 events10 affected141 at risk
Blood creatinine increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0008 events8 affected141 at risk EG0019 events6 affected141 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0009 events7 affected141 at risk EG0018 events8 affected141 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG00013 events12 affected141 at risk EG0015 events5 affected141 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0009 events8 affected141 at risk EG0018 events7 affected141 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG00024 events20 affected141 at risk EG0019 events9 affected141 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG00014 events12 affected141 at risk EG0014 events4 affected141 at risk
Hypertension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0009 events8 affected141 at risk EG0012 events2 affected141 at risk

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D002292	Carcinoma, Renal Cell
D008545	Melanoma

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
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D007680	Kidney Neoplasms
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D007674	Kidney Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009380	Neoplasms, Nerve Tissue
D018326	Nevi and Melanomas
D012878	Skin Neoplasms
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases