Trial Outcomes & Findings for Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients (NCT NCT03049189)
NCT ID: NCT03049189
Last Updated: 2026-04-06
Results Overview
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.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
324 participants
Primary outcome timeframe
From date of randomization until the date of first documented progression or death, assessed up to 30 months,
Results posted on
2026-04-06
Participant Flow
The study was conducted in 14 countries. Of the 52 sites that screened at least one participant, 49 sites randomized at least one participant. A total of 324 participants were enrolled in the study. Of these, 309 (95.4%) were randomized in a 2:1 fashion to the 177Lu-edotreotide arm or the control arm. Of the 309 randomized participants, 7 did not receive treatment.
The COMPETE protocol included Sub-Study C, to evaluate PK urine analysis and bone marrow dosimetry for 177Lu-edotreotide. Sub-Study C enrolled participants from the 177Lu-edotreotide arm of the COMPETE study and a non-randomized cohort. All participants in Sub-Study C received 177Lu-edotreotide.
Participant milestones
| Measure |
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)
|
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)
|
Non-Randomized Participants of Sub-Study C
15 participants were enrolled in the non-randomized cohort of Sub-Study C. Partiipatns in Sub-Study C were were treated with 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)
|
|---|---|---|---|
|
Overall Study
STARTED
|
203
|
99
|
14
|
|
Overall Study
Safety Analysis Set (SAF)
|
203
|
99
|
14
|
|
Overall Study
Full Analysis Set (FAS)
|
207
|
102
|
0
|
|
Overall Study
COMPLETED
|
63
|
18
|
4
|
|
Overall Study
NOT COMPLETED
|
140
|
81
|
10
|
Reasons for withdrawal
| Measure |
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)
|
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)
|
Non-Randomized Participants of Sub-Study C
15 participants were enrolled in the non-randomized cohort of Sub-Study C. Partiipatns in Sub-Study C were were treated with 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)
|
|---|---|---|---|
|
Overall Study
Progressive Disease
|
107
|
53
|
9
|
|
Overall Study
Adverse Event
|
17
|
13
|
0
|
|
Overall Study
Protocol Violation
|
3
|
2
|
0
|
|
Overall Study
Non-compliance
|
1
|
2
|
0
|
|
Overall Study
Pregnancy
|
0
|
1
|
0
|
|
Overall Study
Death
|
7
|
5
|
0
|
|
Overall Study
Other (including Withdrawal by subject, Sponsor request, Technical problems)
|
5
|
5
|
0
|
|
Overall Study
Other: Ongoing
|
0
|
0
|
1
|
Baseline Characteristics
Results are based on analysis of 203 participants in the 177Lu-edotreotide arm and 95 participants in the Everolimus arm.
Baseline characteristics by cohort
| Measure |
177Lu-edotreotide PRRT
n=207 Participants
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)
|
Everolimus
n=102 Participants
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)
|
Total
n=309 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.8 Years
STANDARD_DEVIATION 11.6 • n=207 Participants
|
59.7 Years
STANDARD_DEVIATION 12.2 • n=102 Participants
|
61.7 Years
STANDARD_DEVIATION 11.9 • n=309 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=207 Participants
|
44 Participants
n=102 Participants
|
141 Participants
n=309 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=207 Participants
|
58 Participants
n=102 Participants
|
168 Participants
n=309 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=207 Participants
|
4 Participants
n=102 Participants
|
8 Participants
n=309 Participants
|
|
Race/Ethnicity, Customized
White
|
177 Participants
n=207 Participants
|
84 Participants
n=102 Participants
|
261 Participants
n=309 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=207 Participants
|
1 Participants
n=102 Participants
|
1 Participants
n=309 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
26 Participants
n=207 Participants
|
13 Participants
n=102 Participants
|
39 Participants
n=309 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
6 Participants
n=207 Participants
|
9 Participants
n=102 Participants
|
15 Participants
n=309 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
193 Participants
n=207 Participants
|
89 Participants
n=102 Participants
|
282 Participants
n=309 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
8 Participants
n=207 Participants
|
4 Participants
n=102 Participants
|
12 Participants
n=309 Participants
|
|
Weight
|
73.70 Kg
STANDARD_DEVIATION 15.14 • n=203 Participants • Results are based on analysis of 203 participants in the 177Lu-edotreotide arm and 95 participants in the Everolimus arm.
|
74.13 Kg
STANDARD_DEVIATION 15.72 • n=95 Participants • Results are based on analysis of 203 participants in the 177Lu-edotreotide arm and 95 participants in the Everolimus arm.
|
73.84 Kg
STANDARD_DEVIATION 15.30 • n=298 Participants • Results are based on analysis of 203 participants in the 177Lu-edotreotide arm and 95 participants in the Everolimus arm.
|
|
BMI (Body Mass Index)
|
25.59 Kg/m2
STANDARD_DEVIATION 4.48 • n=203 Participants • Results are based on analysis of 203 participants in the 177Lu-edotreotide arm and 95 participants in the Everolimus arm.
|
25.32 Kg/m2
STANDARD_DEVIATION 4.50 • n=95 Participants • Results are based on analysis of 203 participants in the 177Lu-edotreotide arm and 95 participants in the Everolimus arm.
|
25.51 Kg/m2
STANDARD_DEVIATION 4.48 • n=298 Participants • Results are based on analysis of 203 participants in the 177Lu-edotreotide arm and 95 participants in the Everolimus arm.
|
|
Height
|
169.47 cm
STANDARD_DEVIATION 9.59 • n=203 Participants • Results are based on analysis of 203 participants in the 177Lu-edotreotide arm and 95 participants in the Everolimus arm.
|
170.80 cm
STANDARD_DEVIATION 9.80 • n=95 Participants • Results are based on analysis of 203 participants in the 177Lu-edotreotide arm and 95 participants in the Everolimus arm.
|
169.89 cm
STANDARD_DEVIATION 9.66 • n=298 Participants • Results are based on analysis of 203 participants in the 177Lu-edotreotide arm and 95 participants in the Everolimus arm.
|
PRIMARY outcome
Timeframe: From date of randomization until the date of first documented progression or death, assessed up to 30 months,Population: 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.
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.
Outcome measures
| Measure |
177Lu-edotreotide PRRT
n=207 Participants
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)
|
Everolimus
n=102 Participants
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)
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
23.9 Months
Interval 18.7 to 30.0
|
14.1 Months
Interval 9.2 to 20.9
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: 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.
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.
Outcome measures
| Measure |
177Lu-edotreotide PRRT
n=201 Participants
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)
|
Everolimus
n=95 Participants
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)
|
|---|---|---|
|
Objective Response Rate (ORR)
|
21.9 Percentage of participants
Interval 16.2 to 27.6
|
4.2 Percentage of participants
Interval 0.2 to 8.2
|
SECONDARY outcome
Timeframe: Overall Survival (OS) will be followed up for 5 years (60 months) after the End of Study (EOS)Population: Full Analysis Set (FAS)
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.
Outcome measures
Outcome data not reported
Adverse Events
177Lu-edotreotide PRRT
Serious events: 66 serious events
Other events: 204 other events
Deaths: 14 deaths
Everolimus
Serious events: 44 serious events
Other events: 98 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
177Lu-edotreotide PRRT
n=217 participants at risk
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)
|
Everolimus
n=99 participants at risk
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)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Blood and lymphatic system disorders
Myelosupression
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Cardiac disorders
Angina pectoris
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Cardiac disorders
Atrial fibrillation
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Cardiac disorders
Carcinoid heart disease
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Cardiac disorders
Cardiac arrest
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
2.0%
2/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Endocrine disorders
Ectopic ACTH syndrome
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Eye disorders
Aphakia
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Anal fistula
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Ascites
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Colitis
|
0.92%
2/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.4%
3/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Ileus
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.92%
2/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
3.0%
3/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Melaena
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.4%
3/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.4%
3/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Subileus
|
0.92%
2/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.92%
2/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Vomiting
|
0.92%
2/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
General disorders
Asthenia
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
General disorders
Death
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
General disorders
Disease progression
|
1.4%
3/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
2.0%
2/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
General disorders
General physical health deterioration
|
0.92%
2/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
General disorders
Oedema peripheral
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
General disorders
Pain
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
General disorders
Pyrexia
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
2.0%
2/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Hepatobiliary disorders
Cholangitis
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Hepatobiliary disorders
Cholecystitis
|
2.3%
5/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
2.0%
2/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.4%
3/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Hepatobiliary disorders
Hepatitis
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Immune system disorders
Multisystem inflammatory syndrome
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Infections and infestations
Anorectal infection
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Infections and infestations
COVID-19
|
0.92%
2/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
2.0%
2/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Infections and infestations
Device related bacteraemia
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.92%
2/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
2.0%
2/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Infections and infestations
Infection
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Infections and infestations
Pneumonia
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
2.0%
2/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Infections and infestations
Post procedural sepsis
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Infections and infestations
Pyelonephritis
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Infections and infestations
Respiratory tract infection
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Infections and infestations
Septic shock
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Infections and infestations
Streptococcal infection
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer haemorrhage
|
0.92%
2/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.92%
2/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Injury, poisoning and procedural complications
Radiation hepatitis
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Injury, poisoning and procedural complications
Traumatic spinal cord compression
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Injury, poisoning and procedural complications
Wrong product administered
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
3.0%
3/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Metabolism and nutrition disorders
Type 3 diabetes mellitus
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
5.1%
5/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Musculoskeletal and connective tissue disorders
Diffuse idiopathic skeletal hyperostosis
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrinoma
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
2.0%
2/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma stage I
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome with excess blasts
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vipoma
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.92%
2/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Product Issues
Device occlusion
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Psychiatric disorders
Depression
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Renal and urinary disorders
Urinary retention
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.92%
2/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Surgical and medical procedures
Therapeutic embolisation
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Vascular disorders
Lymphatic fistula
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Vascular disorders
Shock
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
Other adverse events
| Measure |
177Lu-edotreotide PRRT
n=217 participants at risk
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)
|
Everolimus
n=99 participants at risk
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)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.7%
34/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
27.3%
27/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.1%
9/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
5.1%
5/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
17.1%
37/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.4%
16/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
10.1%
10/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
15.2%
33/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
13.1%
13/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.5%
14/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
4.0%
4/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Abdominal pain
|
23.0%
50/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
20.2%
20/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
13.8%
30/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
12.1%
12/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
5.1%
5/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
31/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
9.1%
9/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Diarrhoea
|
35.9%
78/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
44.4%
44/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Dry mouth
|
2.3%
5/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
9.1%
9/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.5%
14/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
3.0%
3/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Flatulence
|
5.5%
12/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
9.1%
9/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.8%
17/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
6.1%
6/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
12.1%
12/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Nausea
|
36.4%
79/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
21.2%
21/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Stomatitis
|
1.4%
3/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
25.3%
25/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Toothache
|
1.4%
3/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
6.1%
6/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Gastrointestinal disorders
Vomiting
|
12.9%
28/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
19.2%
19/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
General disorders
Asthenia
|
30.0%
65/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
36.4%
36/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
General disorders
Chest pain
|
2.3%
5/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
5.1%
5/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
General disorders
Fatigue
|
24.4%
53/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
17.2%
17/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
General disorders
Mucosal inflammation
|
0.92%
2/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
29.3%
29/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
General disorders
Oedema
|
0.46%
1/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
7.1%
7/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
General disorders
Oedema peripheral
|
5.5%
12/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
29.3%
29/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
General disorders
Pyrexia
|
8.8%
19/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
16.2%
16/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Infections and infestations
COVID-19
|
13.8%
30/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
7.1%
7/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
3/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
6.1%
6/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Infections and infestations
Pneumonia
|
1.4%
3/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
5.1%
5/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Infections and infestations
Tooth infection
|
0.92%
2/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
5.1%
5/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
6/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
7.1%
7/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Infections and infestations
Urinary tract infection
|
6.0%
13/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
7.1%
7/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Investigations
alanine aminotransferase (ALT) increased
|
6.9%
15/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
13.1%
13/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Investigations
aspartate aminotransferase (AST) increased
|
8.3%
18/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
10.1%
10/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Investigations
Blood alkaline phosphatase (AP) increased
|
6.0%
13/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
5.1%
5/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Investigations
gamma-glutamyl transferase (GGT) increased
|
6.9%
15/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
5.1%
5/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Investigations
Weight decreased
|
7.8%
17/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
18.2%
18/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.1%
22/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
22.2%
22/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
9.1%
9/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.5%
12/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
24.2%
24/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
17.1%
37/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
10.1%
10/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.7%
8/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
11.1%
11/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.8%
30/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
15.2%
15/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.5%
25/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
11.1%
11/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.8%
6/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
9.1%
9/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.3%
5/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
5.1%
5/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.9%
15/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
4.0%
4/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Nervous system disorders
Dizziness
|
4.6%
10/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
5.1%
5/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Nervous system disorders
Dysgeusia
|
1.8%
4/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
16.2%
16/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Nervous system disorders
Headache
|
12.0%
26/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
19.2%
19/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Psychiatric disorders
Insomnia
|
5.1%
11/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
7.1%
7/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Renal and urinary disorders
Proteinuria
|
2.3%
5/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
6.1%
6/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.1%
11/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
12.1%
12/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.6%
10/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
11.1%
11/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.4%
3/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
14.1%
14/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
8.1%
8/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.7%
21/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
0.00%
0/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.8%
17/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
14.1%
14/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.8%
6/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
7.1%
7/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
6.1%
6/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.0%
13/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
15.2%
15/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.1%
9/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
24.2%
24/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Vascular disorders
Flushing
|
5.1%
11/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
1.0%
1/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
|
Vascular disorders
Hypertension
|
14.7%
32/217 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
8.1%
8/99 • AEs are collected from the signature of the Informed Consent Form (ICF) until the End of Study (EOS), assessed up to approximately 30 months.
AEs, SAEs and all-cause mortality data is based on the SAF. The SAF included all participants who received at least one dose of any study treatment, including 14 participants treated with 177Lu-edotreotide from the non-randomized cohort of Sub-Study C.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Institution and the Investigator shall not publish study results unless the following conditions are met: (i) the multi- center publication has been published; or, if no such publication has occurred, at least eighteen (18) months \[fallback. twelve (12) months\] have passed since the end of the study and (ii) the proposed publication was submitted to the Sponsor in advance, allowing the Sponsor to review and provide comments.
- Publication restrictions are in place
Restriction type: OTHER