Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET... | NCT03049189

Name	Class
ABX CRO	OTHER
PSI CRO	INDUSTRY

Label	Type	Description	Intervention Names
177Lu-edotreotide PRRT	Experimental	177Lu-edotreotide (177Lu-DOTATOC) A maximum of four cycles of 7.5 ± 0.7 GBq (gigabequerel) 177Lu-edotreotide, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 4 cycles, 90 days apart (total duration: 270 days/9 months)	Drug: 177Lu-edotreotide PRRT Other: Amino-Acid Solution
Everolimus	Active Comparator	Everolimus (Afinitor ®) Doses: 10 mg/d Route of administration: Oral Duration of treatment: Continuous daily treatment until diagnosis of progression or End of Study (EOS)	Drug: Everolimus

Name	Type	Description	Arm Group Labels	Other Names
177Lu-edotreotide PRRT	Drug	PRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered.	177Lu-edotreotide PRRT

Measure	Description	Time Frame
Progression-Free Survival (PFS)	PFS determined as time elapsed between randomization, and the date of first objective report of tumor progression (evaluated by RECIST criteria v1.1) as evaluated by the Blinded Independent Central Review (BICR), or death.	From date of randomization until the date of first documented progression or death, assessed up to 30 months,

Measure	Description	Time Frame
Objective Response Rate (ORR)	ORR will be assessed, defined as the proportion of participants achieving partial response (PR) or complete response (CR) as best outcome, after treatment with 177Lu-edotreotide compared to everolimus.	Up to 30 months
Overall Survival (OS)

Facility	Status	City	State	ZIP	Country	Contacts
Banner Health d.b.a. Banner MD Anderson Cancer Center		Gilbert	Arizona	85234	United States
Stanford University

PubMed Identifier	Type	Citation	Retractions
42392118	Derived	Walter T, Jann H, Ansquer C, Deshayes E, Garcia-Carbonero R, Teule A, Baum RP, Verberne HJ, Cwikla JB, Srirajaskanthan R, de Mestier L, Grana CM, Buck A, Horsch D, Pavel M, Dierickx LO, Michael M, Strosberg J, Kollar A, Jimenez-Fonseca P, Rinke A, Del Olmo-Garcia M, Flaus A, Hernando J, Kluge A, Breuninger M, Melnyk S, Zhernosekov K, Capdevila J; COMPETE Investigator Team. [177Lu]Lu-edotreotide versus everolimus for gastroenteropancreatic neuroendocrine tumours (COMPETE): a phase 3, multicentre, randomised, open-label, superiority trial. Lancet. 2026 Jul 2:S0140-6736(26)00604-5. doi: 10.1016/S0140-6736(26)00604-5. Online ahead of print.

ID	Title	Description
FG000	177Lu-edotreotide PRRT	177Lu-edotreotide A maximum of four cycles of 7.5 ± 0.7 GBq (gigabecquerel) 177Lu-edotreotide, each, until diagnosis of progression or End of Study (EOS). Route of administration: Slow intravenous infusion (i.v.) Duration of treatment: 4 cycles, administered 3-monthly (total duration: 270 days/9 months)
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 29, 2022	Nov 25, 2025

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression-Free Survival (PFS)

PFS determined as time elapsed between randomization, and the date of first objective report of tumor progression (evaluated by RECIST criteria v1.1) as evaluated by the Blinded Independent Central Review (BICR), or death.

PFS analysis is based on the FAS population, i.e., 309 participants randomized in the COMPETE study.

The COMPETE protocol included a Sub-Study C, to evaluate PK urine analysis and bone marrow dosimetry. Sub-Study C enrolled participants from the 177Lu-edotreotide arm of the COMPETE study and a non-randomized cohort.

Participants from the non-randomized cohort were not included in the FAS.

Posted

Median

95% Confidence Interval

Months

From date of randomization until the date of first documented progression or death, assessed up to 30 months,

ID	Title	Description
OG000	177Lu-edotreotide PRRT	177Lu-edotreotide A maximum of four cycles of 7.5 ± 0.7 GBq (gigabecquerel) 177Lu-edotreotide, each, until diagnosis of progression or End of Study (EOS). Route of administration: Slow intravenous infusion (i.v.) Duration of treatment: 4 cycles, administered 3-monthly (total duration: 270 days/9 months)
OG001	Everolimus	Everolimus (Afinitor ®) Doses: 10 mg/d Route of administration: Oral Duration of treatment: Continuous daily treatment until diagnosis of progression or End of Study (EOS)

Units	Counts
Participants	OG000207 OG001102

Title

Denominators

Categories

Title	Measurements
	OG00023.9(18.7 to 30.0) OG00114.1(9.2 to 20.9)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	[Not Specified]	Log Rank	Log-rank test stratified by tumor origin (P- NET vs GE-NET) and prior medical therapy (1st line vs 2nd line).	0.0223	[Not Specified]	Hazard Ratio (HR)	0.673			2-Sided	95	0.477	0.948			Hazard ratio is expressed as 177Lu-edotreotide/everolimus and estimated from the corresponding Cox model.		Superiority	[Not Specified]

Secondary

Objective Response Rate (ORR)

ORR will be assessed, defined as the proportion of participants achieving partial response (PR) or complete response (CR) as best outcome, after treatment with 177Lu-edotreotide compared to everolimus.

ORR analysis is based on the FAS population, i.e., 309 participants randomized in the COMPETE study. However, for the calculations of ORR proportions, the denominators were based on participants with CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE), and not the total randomized participants, resulting in 201 as the denominator for 177Lu-edotreotide and 95 for everolimus.

In addition, participants from the non-randomized cohort were not included in the FAS.

Posted

Number

95% Confidence Interval

Percentage of participants

Up to 30 months

ID	Title	Description
OG000	177Lu-edotreotide PRRT	177Lu-edotreotide (177Lu-DOTATOC) A maximum of four cycles of 7.5 ± 0.7 GBq (gigabequerel) 177Lu-edotreotide, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 4 cycles, 90 days apart (total duration: 270 days/9 months)
OG001	Everolimus	Everolimus (Afinitor ®) Doses: 10 mg/d Route of administration: Oral Duration of treatment: Continuous daily treatment until diagnosis of progression or End of Study (EOS)

Secondary

Overall Survival (OS)

From the date of randomisation until the date of death up to the up to the end of the 5 year post-study follow-up.

Full Analysis Set (FAS)

Not Posted

Dec 2029

Overall Survival (OS) will be followed up for 5 years (60 months) after the End of Study (EOS)

Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Myelosupression	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Angina pectoris	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0011 affected99 at risk
Atrial flutter	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Carcinoid heart disease	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Cardiac arrest	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0011 affected99 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0012 affected99 at risk
Ectopic ACTH syndrome	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Aphakia	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Ascites	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0011 affected99 at risk
Colitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected217 at risk EG0010 affected99 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0011 affected99 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0011 affected99 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Gastritis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0003 affected217 at risk EG0011 affected99 at risk
Ileus	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected217 at risk EG0013 affected99 at risk
Intra-abdominal fluid collection	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Jejunal perforation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Mechanical ileus	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Melaena	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Nausea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Oesophageal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0003 affected217 at risk EG0010 affected99 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0003 affected217 at risk EG0010 affected99 at risk
Subileus	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected217 at risk EG0011 affected99 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected217 at risk EG0011 affected99 at risk
Vomiting	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected217 at risk EG0010 affected99 at risk
Asthenia	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Death	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0011 affected99 at risk
Disease progression	General disorders	MedDRA 27.1	Systematic Assessment	EG0003 affected217 at risk EG0012 affected99 at risk
General physical health deterioration	General disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected217 at risk EG0011 affected99 at risk
Oedema peripheral	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Pyrexia	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0012 affected99 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Biliary obstruction	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0005 affected217 at risk EG0012 affected99 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0003 affected217 at risk EG0011 affected99 at risk
Hepatic haemorrhage	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Hepatic pain	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Multisystem inflammatory syndrome	Immune system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Anal abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Anorectal infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
COVID-19	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 affected217 at risk EG0012 affected99 at risk
Device related bacteraemia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 affected217 at risk EG0010 affected99 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Gastroenteritis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0012 affected99 at risk
Infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Peritonitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Pharyngitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Pneumonia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0012 affected99 at risk
Post procedural sepsis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Pyelonephritis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Septic shock	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Streptococcal infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Tubo-ovarian abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Anastomotic ulcer haemorrhage	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0002 affected217 at risk EG0010 affected99 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0002 affected217 at risk EG0010 affected99 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Radiation hepatitis	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Traumatic spinal cord compression	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Wrong product administered	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0013 affected99 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0011 affected99 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Type 3 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Diffuse idiopathic skeletal hyperostosis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0011 affected99 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Gastrinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0012 affected99 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Invasive breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Malignant melanoma stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0011 affected99 at risk
Myelodysplastic syndrome with excess blasts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Oropharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Vipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected217 at risk EG0010 affected99 at risk
Device occlusion	Product Issues	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Depression	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0015 affected99 at risk
Urinary retention	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected217 at risk EG0010 affected99 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0011 affected99 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk
Therapeutic embolisation	Surgical and medical procedures	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Lymphatic fistula	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected99 at risk
Shock	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected99 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG00034 affected217 at risk EG00127 affected99 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0009 affected217 at risk EG0015 affected99 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG00037 affected217 at risk EG0011 affected99 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG00016 affected217 at risk EG00110 affected99 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG00033 affected217 at risk EG00113 affected99 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00014 affected217 at risk EG0014 affected99 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00050 affected217 at risk EG00120 affected99 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00030 affected217 at risk EG00112 affected99 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0015 affected99 at risk
Constipation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00031 affected217 at risk EG0019 affected99 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00078 affected217 at risk EG00144 affected99 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0005 affected217 at risk EG0019 affected99 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00014 affected217 at risk EG0013 affected99 at risk
Flatulence	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00012 affected217 at risk EG0019 affected99 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00017 affected217 at risk EG0016 affected99 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG00112 affected99 at risk
Nausea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00079 affected217 at risk EG00121 affected99 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0003 affected217 at risk EG00125 affected99 at risk
Toothache	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0003 affected217 at risk EG0016 affected99 at risk
Vomiting	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00028 affected217 at risk EG00119 affected99 at risk
Asthenia	General disorders	MedDRA 27.1	Systematic Assessment	EG00065 affected217 at risk EG00136 affected99 at risk
Chest pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0005 affected217 at risk EG0015 affected99 at risk
Fatigue	General disorders	MedDRA 27.1	Systematic Assessment	EG00053 affected217 at risk EG00117 affected99 at risk
Mucosal inflammation	General disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected217 at risk EG00129 affected99 at risk
Oedema	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected217 at risk EG0017 affected99 at risk
Oedema peripheral	General disorders	MedDRA 27.1	Systematic Assessment	EG00012 affected217 at risk EG00129 affected99 at risk
Pyrexia	General disorders	MedDRA 27.1	Systematic Assessment	EG00019 affected217 at risk EG00116 affected99 at risk
COVID-19	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00030 affected217 at risk EG0017 affected99 at risk
Nasopharyngitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0003 affected217 at risk EG0016 affected99 at risk
Pneumonia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0003 affected217 at risk EG0015 affected99 at risk
Tooth infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 affected217 at risk EG0015 affected99 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0006 affected217 at risk EG0017 affected99 at risk
Urinary tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00013 affected217 at risk EG0017 affected99 at risk
alanine aminotransferase (ALT) increased	Investigations	MedDRA 27.1	Systematic Assessment	EG00015 affected217 at risk EG00113 affected99 at risk
aspartate aminotransferase (AST) increased	Investigations	MedDRA 27.1	Systematic Assessment	EG00018 affected217 at risk EG00110 affected99 at risk
Blood alkaline phosphatase (AP) increased	Investigations	MedDRA 27.1	Systematic Assessment	EG00013 affected217 at risk EG0015 affected99 at risk
gamma-glutamyl transferase (GGT) increased	Investigations	MedDRA 27.1	Systematic Assessment	EG00015 affected217 at risk EG0015 affected99 at risk
Weight decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG00017 affected217 at risk EG00118 affected99 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG00022 affected217 at risk EG00122 affected99 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0019 affected99 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG00012 affected217 at risk EG00124 affected99 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG00037 affected217 at risk EG0010 affected99 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG00110 affected99 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0008 affected217 at risk EG00111 affected99 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG00030 affected217 at risk EG00115 affected99 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG00025 affected217 at risk EG00111 affected99 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0006 affected217 at risk EG0019 affected99 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0005 affected217 at risk EG0015 affected99 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG00015 affected217 at risk EG0014 affected99 at risk
Dizziness	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG00010 affected217 at risk EG0015 affected99 at risk
Dysgeusia	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0004 affected217 at risk EG00116 affected99 at risk
Headache	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG00026 affected217 at risk EG00119 affected99 at risk
Insomnia	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG00011 affected217 at risk EG0017 affected99 at risk
Proteinuria	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0005 affected217 at risk EG0016 affected99 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG00011 affected217 at risk EG00112 affected99 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG00010 affected217 at risk EG00111 affected99 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0003 affected217 at risk EG00114 affected99 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0018 affected99 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG00021 affected217 at risk EG0010 affected99 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG00017 affected217 at risk EG00114 affected99 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0006 affected217 at risk EG0017 affected99 at risk
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected217 at risk EG0016 affected99 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG00013 affected217 at risk EG00115 affected99 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0009 affected217 at risk EG00124 affected99 at risk
Flushing	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG00011 affected217 at risk EG0011 affected99 at risk
Hypertension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG00032 affected217 at risk EG0018 affected99 at risk

ID	Term
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009380	Neoplasms, Nerve Tissue

ID	Term
C504257	177Lu-octreotide, DOTA(0)-Tyr(3)-
D000068338	Everolimus
C545824	amino-acid, glucose, and electrolyte solution

ID	Term
D020123	Sirolimus
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals

ID	Title	Description
BG000	177Lu-edotreotide PRRT	177Lu-edotreotide A maximum of four cycles of 7.5 ± 0.7 GBq (gigabecquerel) 177Lu-edotreotide, each, until diagnosis of progression or End of Study (EOS). Route of administration: Slow intravenous infusion (i.v.) Duration of treatment: 4 cycles, administered 3-monthly (total duration: 270 days/9 months)
BG001	Everolimus	Everolimus (Afinitor ®) Doses: 10 mg/d Route of administration: Oral Duration of treatment: Continuous daily treatment until diagnosis of progression or End of Study (EOS)
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	177Lu-edotreotide PRRT	177Lu-edotreotide A maximum of four cycles of 7.5 ± 0.7 GBq (gigabecquerel) 177Lu-edotreotide, each, until diagnosis of progression or End of Study (EOS). Route of administration: Slow intravenous infusion (i.v.) Duration of treatment: 4 cycles, administered 3-monthly (total duration: 270 days/9 months)	14	217	66	217	204	217
EG001	Everolimus	Everolimus (Afinitor ®) Doses: 10 mg/d Route of administration: Oral Duration of treatment: Continuous daily treatment until diagnosis of progression or End of Study (EOS)	7	99	44	99	98	99