A Dose Escalation and Cohort Expansion Study of NKTR-214... | NCT02983045

Name	Class
Bristol-Myers Squibb	INDUSTRY

Label	Type	Description	Intervention Names
Dose Escalation: Combination of NKTR-214 + nivolumab	Experimental	NKTR 214 + nivolumab at 5 dosage levels to determine the RP2D Part 1 of RP2D in patients with advanced or metastatic melanoma, RCC, NSCLC, urothelial carcinoma, or TNBC.	Drug: Dose Escalation Doublet: Combination of NKTR-214 + nivolumab
Dose Expansion: Combination of NKTR-214 + nivolumab	Experimental	NKTR-214+nivolumab in patients with advanced or metastatic solid tumor malignancies to assess the efficacy of the RP2D.	Drug: Dose Expansion Doublet: Combination of NKTR-214 + nivolumab
Experimental: Combination of NKTR-214 + nivolumab + ipilimumab	Experimental	To assess the safety and tolerability of NKTR 214 + nivolumab + ipilimumab triplet therapy and establish RP2D dosing schedules for Part 4 in patients with advanced or metastatic melanoma, RCC, NSCLC, or UCC in a first-line setting (1L).	Drug: Schedule Finding Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab
Experimental: Dose Expansion of Part 3	Experimental	To further assess the RP2D triplet combination dosing schedules from Part 3 in 1L NSCLC and 1L RCC patients.	Drug: Dose Expansion Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab

Name	Type	Description	Arm Group Labels	Other Names
Dose Escalation Doublet: Combination of NKTR-214 + nivolumab	Drug	NKTR 214 + nivolumab at 5 dosage levels.	Dose Escalation: Combination of NKTR-214 + nivolumab

Measure	Description	Time Frame
Part 1 Dose Escalation: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window	Part 1of the study was a dose-escalation phase that evaluated the safety and tolerability and defined the maximum tolerated dose or recommended Phase 2 dose of the NKTR-214/nivolumab doublet across 5 dosage/schedule levels. The results presented are for the DLT Population.	Includes DLTs that occurred within the DLT window of at least 21 days after the first dose of study treatment (28 days for every 2 weeks dosing; 21 days for every 3 weeks dosing). Patients were counted only once under each preferred term.
Part 3 Schedule Finding: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window	Part 3 of the study was a schedule finding phase to establish the recommended phase 2 dosing schedules for Part 4 and assess the safety and tolerability for the NKTR-214/nivolumab/ipilimumab triplet combination. The results presented are for the DLT Population.	Dose-limiting toxicities (DLTs) were assessed during a 3-week (21-day) DLT evaluation period beginning with the first dose of ipilimumab.
Part 2 and Part 4: Objective Response Rate (ORR) Per RECIST 1.1 at Recommended Phase 2 Dose (RP2D)	Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) at Recommended Phase 2 Dose (RP2D). ORR is defined as the percentage of enrolled participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR.	Tumor assessment at Screening then every 8 weeks (± 7 days) from Cycle 1 Day 1 and end of treatment (unless scan done within 4 weeks) up to approximately 27 months.

Name	Affiliation	Role
Study Director	Nektar Therapeutics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
UCSD, Moores Cancer Center		La Jolla	California	92093	United States
UCLA

PubMed Identifier	Type	Citation	Retractions
41811823	Derived	Bautista J, Echeverria CE, Maldonado-Noboa I, Adatty-Molina J, Suarez Urresta S, Coral-Riofrio EC, Araujo-Abad S, Kyriakidis NC, Lopez-Cortes A. Next-Generation Immune Checkpoints and Tumor Microenvironment Modulation in Cancer Immunotherapy. J Immunol Res. 2026;2026(1):e7864229. doi: 10.1155/jimr/7864229.
35643589	Derived

ID	Title	Description
FG000	Part 1 Dose Escalation Cohort 1: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (240 mg) q2w	NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 240 mg nivolumab q2w.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 11, 2020	Nov 29, 2022

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Primary

Part 1 Dose Escalation: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window

Part 1of the study was a dose-escalation phase that evaluated the safety and tolerability and defined the maximum tolerated dose or recommended Phase 2 dose of the NKTR-214/nivolumab doublet across 5 dosage/schedule levels. The results presented are for the DLT Population.

The DLT population included all Part 1 patients who took study treatment and followed up at least through the DLT evaluation period (q2w dosing: received ≥ 2 cycles of study treatment and stayed in study for at least 28 days; q3w dosing: received at least 1 cycle of study treatment and stayed in study for at least 21 days) or discontinued from study treatment due to DLT.

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Participants

Includes DLTs that occurred within the DLT window of at least 21 days after the first dose of study treatment (28 days for every 2 weeks dosing; 21 days for every 3 weeks dosing). Patients were counted only once under each preferred term.

ID	Title	Description
OG000	Dose Escalation Cohort 1: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (240 mg) q2w	NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 240 mg nivolumab q2w.
OG001	Dose Escalation Cohort 2: NKTR-214 (0.006 mg/kg) q2w + Nivolumab (240 mg) q2w	NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.006 mg/kg administered every 2 weeks (q2w) in combination with 240 mg nivolumab q2w.
OG002	Dose Escalation Cohort 3: NKTR-214 (0.003 mg/kg) q2w + Nivolumab (240 mg) q2w	NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.003 mg/kg administered every 2 weeks (q2w) in combination with 240 mg nivolumab q2w.
OG003	Dose Escalation Cohort 4: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w	NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.
OG004	Dose Escalation Cohort 5: NKTR-214 (0.009 mg/kg) q3w + Nivolumab (360 mg) q3w	NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.009 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.

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Participants	OG0004 OG0013 OG0023 OG003

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At least 1 DLT

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	OG0000 OG0010 OG0020 OG003

Primary

Part 3 Schedule Finding: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window

Part 3 of the study was a schedule finding phase to establish the recommended phase 2 dosing schedules for Part 4 and assess the safety and tolerability for the NKTR-214/nivolumab/ipilimumab triplet combination. The results presented are for the DLT Population.

The DLT population included all Part 3 patients who received at least 1 cycle of study treatment and stayed in study for at least 21 days after first dose of ipilimumab or discontinued from study treatment due to DLT.

Posted

Count of Participants

Participants

Dose-limiting toxicities (DLTs) were assessed during a 3-week (21-day) DLT evaluation period beginning with the first dose of ipilimumab.

ID	Title	Description
OG000	Schedule Finding (Schedule 1): NKTR-214 + Nivolumab + Ipilimumab	In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4. In Schedule 1, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 360 mg flat dose q3w + ipilimumab at 1 mg/kg q6w.
OG001	Schedule Finding (Schedule 2): NKTR-214 + Nivolumab + Ipilimumab	In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4. In Schedule 2, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 1 mg/kg q3w + ipilimumab at 3 mg/kg q3w for four cycles, followed by the maintenance dose of NKTR-214 0.006 mg/kg and nivolumab 360 mg q3w.

Primary

Part 2 and Part 4: Objective Response Rate (ORR) Per RECIST 1.1 at Recommended Phase 2 Dose (RP2D)

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) at Recommended Phase 2 Dose (RP2D).

ORR is defined as the percentage of enrolled participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR.

The response evaluable population included patients who had measurable disease (per RECIST 1.1) at baseline and also had at least 1 postbaseline assessment of tumor response prior to receiving new systemic anticancer therapy, surgical procedures or radiotherapy on target lesions.

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Count of Participants

Participants

Tumor assessment at Screening then every 8 weeks (± 7 days) from Cycle 1 Day 1 and end of treatment (unless scan done within 4 weeks) up to approximately 27 months.

ID	Title	Description
OG000	Part 2 Dose Expansion: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w	In this Part 2 of the study, the patients received a combination of NKTR-214 + nivolumab at the RP2D (NKTR 214 0.006 mg/kg q3w + nivolumab 360 mg q3w) with or without chemotherapy.
OG001	Part 4 Dose Expansion of NKTR-214 + Nivolumab + Ipilimumab

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG0030 affected25 at risk EG004
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Diaphragmatic spasm	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Laryngeal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pneumonia	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Sepsis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Cellulitis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Bronchitis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Corona virus infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Infectious pleural effusion	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Abscess soft tissue	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Bursitis infective staphylococcal	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Device related infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Device related sepsis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Lower respiratory tract infection viral	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Lung infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Systemic infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Urosepsis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pyrexia	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pain	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Fatigue	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Malaise	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Asthenia	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Chills	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Face oedema	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
General physical health deterioration	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Influenza like illness	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Oedema peripheral	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Faecaloma	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Myocarditis	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Arrhythmia supraventricular	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pericarditis	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Embolic stroke	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Headache	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Dizziness	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Brain oedema	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Facial paralysis	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hydrocephalus	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Myasthenia gravis	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Seizure	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Somnolence	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Spinal cord compression	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Syncope	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Vasogenic cerebral oedema	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hypotension	Vascular disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Embolism	Vascular disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Superior vena cava syndrome	Vascular disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hypertension	Vascular disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Vena cava thrombosis	Vascular disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Venous thrombosis	Vascular disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Acidosis	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Autoimmune nephritis	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Obstructive uropathy	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Intracranial tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Oesophageal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Eosinophilia	Blood and lymphatic system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hypereosinophilic syndrome	Blood and lymphatic system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Autoimmune hypothyroidism	Endocrine disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hypophysitis	Endocrine disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Thyroiditis	Endocrine disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Drug reaction with eosinophilia and systemic symptoms	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Blood creatinine increased	Investigations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Cytokine release syndrome	Immune system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Contrast media allergy	Immune system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hallucination	Psychiatric disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Visual impairment	Eye disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Fatigue	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0004 affected4 at risk EG0012 affected3 at risk EG0021 affected3 at risk EG00319 affected25 at risk EG0042 affected3 at risk EG005241 affected476 at risk EG0069 affected10 at risk EG0075 affected8 at risk EG0086 affected6 at risk EG00915 affected19 at risk
Pyrexia	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0004 affected4 at risk EG0013 affected3 at risk EG0022 affected3 at risk EG003
Influenza like illness	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0003 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Chills	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0003 affected4 at risk EG0013 affected3 at risk EG0023 affected3 at risk EG003
Oedema peripheral	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0012 affected3 at risk EG0021 affected3 at risk EG003
Asthenia	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Face oedema	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0002 affected4 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Malaise	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0002 affected4 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pain	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Peripheral swelling	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Mucosal inflammation	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Localised oedema	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Oedema	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Generalised oedema	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Gait disturbance	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Axillary pain	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hernia	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hypothermia	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0003 affected4 at risk EG0011 affected3 at risk EG0021 affected3 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0003 affected4 at risk EG0012 affected3 at risk EG0022 affected3 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0002 affected4 at risk EG0011 affected3 at risk EG0021 affected3 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0002 affected4 at risk EG0011 affected3 at risk EG0021 affected3 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0011 affected3 at risk EG0021 affected3 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected3 at risk EG0021 affected3 at risk EG003
Swollen tongue	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Tongue oedema	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Anal haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Oral disorder	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Oral dysaesthesia	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0002 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Retching	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Abdominal rigidity	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Anal fistula	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Frequent bowel movements	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Lip oedema	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Salivary gland pain	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0002 affected4 at risk EG0012 affected3 at risk EG0022 affected3 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0003 affected4 at risk EG0011 affected3 at risk EG0022 affected3 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0012 affected3 at risk EG0021 affected3 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0003 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Skin hypopigmentation	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Vitiligo	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Dermatitis exfoliative	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Dermatitis bullous	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Skin mass	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Eczema asteatotic	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Keloid scar	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Rash vesicular	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Skin induration	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0011 affected3 at risk EG0021 affected3 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0002 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0002 affected4 at risk EG0011 affected3 at risk EG0023 affected3 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0002 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pharyngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Sputum increased	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Upper airway obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pulmonary pain	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Throat tightness	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0004 affected4 at risk EG0011 affected3 at risk EG0022 affected3 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0003 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0002 affected4 at risk EG0012 affected3 at risk EG0020 affected3 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0012 affected3 at risk EG0021 affected3 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Soft tissue swelling	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment	EG0003 affected4 at risk EG0012 affected3 at risk EG0020 affected3 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Fluid retention	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Headache	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0004 affected4 at risk EG0011 affected3 at risk EG0021 affected3 at risk EG003
Dizziness	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Syncope	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0002 affected4 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Memory impairment	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Presyncope	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Sciatica	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Somnolence	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Tremor	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Dizziness postural	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Aphasia	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Dysaesthesia	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Sinus headache	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Akathisia	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Balint's syndrome	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Facial paralysis	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Hemianopia	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Vasogenic cerebral oedema	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Visual field defect	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Weight decreased	Investigations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Blood creatinine increased	Investigations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Weight increased	Investigations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Lipase increased	Investigations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected3 at risk EG0021 affected3 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Amylase increased	Investigations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Transaminases increased	Investigations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Eosinophil count increased	Investigations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Blood pressure increased	Investigations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
White blood cell count increased	Investigations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Troponin I increased	Investigations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Blood creatine increased	Investigations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hypotension	Vascular disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0011 affected3 at risk EG0021 affected3 at risk EG003
Hypertension	Vascular disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Flushing	Vascular disorders	MedDRA 19.0	Non-systematic Assessment	EG0003 affected4 at risk EG0012 affected3 at risk EG0021 affected3 at risk EG003
Hot flush	Vascular disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Embolism	Vascular disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Thrombophlebitis superficial	Vascular disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Sinusitis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pneumonia	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Bronchitis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Influenza	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Skin infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Eye infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Mucosal infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Wound infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Gastroenteritis pseudomonas	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Groin infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pneumonia streptococcal	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Post procedural cellulitis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Soft tissue infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0012 affected3 at risk EG0020 affected3 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Restlessness	Psychiatric disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Claustrophobia	Psychiatric disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 19.0	Non-systematic Assessment	EG0002 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Thyroiditis	Endocrine disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hypogonadism	Endocrine disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hypophysitis	Endocrine disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Dry eye	Eye disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected3 at risk EG0021 affected3 at risk EG003
Vision blurred	Eye disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Periorbital oedema	Eye disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Eye swelling	Eye disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Lacrimation increased	Eye disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Eyelid oedema	Eye disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Photophobia	Eye disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Eye pain	Eye disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Eye irritation	Eye disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Vitreous floaters	Eye disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected3 at risk EG0021 affected3 at risk EG003
Orbital oedema	Eye disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Chalazion	Eye disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Sunburn	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Eosinophilia	Blood and lymphatic system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Palpitations	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Stress cardiomyopathy	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Nocturia	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Micturition urgency	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Chromaturia	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Bladder spasm	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Nephritis	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Nephrotic syndrome	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Urine odour abnormal	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected4 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Testicular pain	Reproductive system and breast disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Perineal pain	Reproductive system and breast disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Contrast media allergy	Immune system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Skin neoplasm bleeding	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003

ID	Title	Description
BG000	Part 1 Dose Escalation Cohort 1: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (240 mg) q2w	NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 240 mg nivolumab q2w.
BG001	Part 1 Dose Escalation Cohort 2: NKTR-214 (0.006 mg/kg) q2w + Nivolumab (240 mg) q2w	NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.006 mg/kg administered every 2 weeks (q2w) in combination with 240 mg nivolumab q2w.
BG002	Part 1 Dose Escalation Cohort 3: NKTR-214 (0.003 mg/kg) q2w + Nivolumab (240 mg) q2w	NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.003 mg/kg administered every 2 weeks (q2w) in combination with 240 mg nivolumab q2w.
BG003	Part 1 Dose Escalation Cohort 4: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w	NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.
BG004	Part 1 Dose Escalation Cohort 5: NKTR-214 (0.009 mg/kg) q3w + Nivolumab (360 mg) q3w	NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.009 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.
BG005	Part 2 Dose Expansion: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w	In this Part 2 of the study, the patients will receive a combination of NKTR-214 + nivolumab at the RP2D (NKTR 214 0.006 mg/kg q3w + nivolumab 360 mg q3w) with or without chemotherapy.
BG006	Part 3 Schedule Finding (Schedule 1): NKTR-214 + Nivolumab + Ipilimumab	In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4. In Schedule 1, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 360 mg flat dose q3w + ipilimumab at 1 mg/kg q6w.
BG007	Part 3 Schedule Finding (Schedule 2): NKTR-214 + Nivolumab + Ipilimumab	In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4. In Schedule 2, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 1 mg/kg q3w + ipilimumab at 3 mg/kg q3w for four cycles, followed by the maintenance dose of NKTR-214 0.006 mg/kg and nivolumab 360 mg q3w.
BG008	Part 3 Schedule Finding (Schedule 3): NKTR-214 + Nivolumab + Ipilimumab	In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4. In Schedule 3, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 3 mg/kg q3w + ipilimumab at 1 mg/kg q3w for four cycles, followed by the maintenance dose of NKTR-214 0.006 mg/kg and nivolumab 360 mg q3w.
BG009	Part 4 Dose Expansion of NKTR-214 + Nivolumab + Ipilimumab	Experimental Combination of NKTR-214 + nivolumab ipilimumab that may enroll between 12-26 patients per tumor type Combination of NKTR-214 + nivolumab: Combination of NKTR-214 + nivolumab +ipilimumab administered at the RP2D dose/schedule.
BG010	Total	Total of all reporting groups

ID	Term
D008545	Melanoma
D002292	Carcinoma, Renal Cell
D002289	Carcinoma, Non-Small-Cell Lung
D002295	Carcinoma, Transitional Cell
D064726	Triple Negative Breast Neoplasms
D013274	Stomach Neoplasms
D015179	Colorectal Neoplasms
D009362	Neoplasm Metastasis

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009380	Neoplasms, Nerve Tissue
D018326	Nevi and Melanomas
D012878	Skin Neoplasms
D009371	Neoplasms by Site
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
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
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D001943	Breast Neoplasms
D001941	Breast Diseases
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D013272	Stomach Diseases
D007414	Intestinal Neoplasms
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000077594	Nivolumab
C000611752	bempegaldesleukin
D016190	Carboplatin
D002945	Cisplatin
D000068437	Pemetrexed
D017239	Paclitaxel

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D056831	Coordination Complexes
D009930	Organic Chemicals
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
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
D000600	Amino Acids, Dicarboxylic
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D004224	Diterpenes
D013729	Terpenes

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part 1 Dose Escalation Cohort 1: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (240 mg) q2w	NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 240 mg nivolumab q2w.	2	4	2	4	4	4
EG001	Part 1 Dose Escalation Cohort 2: NKTR-214 (0.006 mg/kg) q2w + Nivolumab (240 mg) q2w	NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.006 mg/kg administered every 2 weeks (q2w) in combination with 240 mg nivolumab q2w.	1	3	0	3	3	3
EG002	Part 1 Dose Escalation Cohort 3: NKTR-214 (0.003 mg/kg) q2w + Nivolumab (240 mg) q2w	NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.003 mg/kg administered every 2 weeks (q2w) in combination with 240 mg nivolumab q2w.	2	3	1	3	3	3
EG003	Part 1 Dose Escalation Cohort 4: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w	NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.	10	25	9	25	25	25
EG004	Part 1 Dose Escalation Cohort 5: NKTR-214 (0.009 mg/kg) q3w + Nivolumab (360 mg) q3w	NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.009 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.	1	3	2	3	3	3
EG005	Part 2 Dose Expansion: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w	In this Part 2 of the study, the patients will receive a combination of NKTR-214 + nivolumab at the RP2D (NKTR 214 0.006 mg/kg q3w + nivolumab 360 mg q3w) with or without chemotherapy.	291	476	213	476	468	476
EG006	Part 3 Schedule Finding (Schedule 1): NKTR-214 + Nivolumab + Ipilimumab	In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4. In Schedule 1, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 360 mg flat dose q3w + ipilimumab at 1 mg/kg q6w.	2	10	6	10	10	10
EG007	Part 3 Schedule Finding (Schedule 2): NKTR-214 + Nivolumab + Ipilimumab	In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4. In Schedule 2, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 1 mg/kg q3w + ipilimumab at 3 mg/kg q3w for four cycles, followed by the maintenance dose of NKTR-214 0.006 mg/kg and nivolumab 360 mg q3w.	3	8	5	8	8	8
EG008	Part 3 Schedule Finding (Schedule 3): NKTR-214 + Nivolumab + Ipilimumab	In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4. In Schedule 3, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 3 mg/kg q3w + ipilimumab at 1 mg/kg q3w for four cycles, followed by the maintenance dose of NKTR-214 0.006 mg/kg and nivolumab 360 mg q3w.	1	6	2	6	6	6
EG009	Part 4 Dose Expansion of NKTR-214 + Nivolumab + Ipilimumab	Experimental Combination of NKTR-214 + nivolumab + ipilimumab. Combination of NKTR-214 + nivolumab: Combination of NKTR-214 + nivolumab +ipilimumab administered at the RP2D dose/schedule.	5	19	8	19	19	19