Gastroenteropancreatic Neuroendocrine Tumors
Conditions
Keywords
GEP-NET, Neuroendocrine tumors, NETs, carcinoid tumors, LysaKare, arginine/lysine, amino acid, Peptide Receptor Radionuclide Therapy, PRRT, Lutathera, Lutetium Lu 177 oxodotreotide, Lutetium Lu 177 dotatate
Brief summary
The purpose of the study was to evaluate the effect of arginine/lysine solution administration on serum potassium levels. A systematic assessment of serum potassium levels was performed during infusion and up to 24 hours post start of infusion compared to baseline.
Detailed description
The study schedule for each patient consisted of a screening period followed by an infusion day with an optional overnight in-clinic stay, and a follow up call 48h post infusion. Screening Phase: At screening, patient eligibility was determined according to inclusion and exclusion criteria, with evaluation of patient's vital signs, ECG and laboratory parameters. The duration of screening could be as short as one day but could not exceed 7 days. Patients who showed potassium level \> 6.0 mmol/L (\> 5.5 mmol/L for Poland only) at screening could have their potassium level corrected and could be re-screened afterwards. Treatment Phase: Eligible patients were admitted to the in-clinic unit and dosed with arginine/lysine solution for infusion of 1,000 mL, which was administered intravenously over a period of 4 hours. Before the infusion (at 0 h time point), a set of baseline tests were performed. During and after the infusion, patient condition was monitored for evaluation of any adverse events. Only patients with a potassium level of ≤ 6 mmol/L at screening (\> 5.5 mmol/L for Poland only) were allowed to be dosed. Potassium testing on the infusion day was performed at 0h (before the infusion), and at 2h, 4h, 6h, 8h, 12h, and 24h after the start of infusion. Vital signs and ECGs were taken as specified in the assessment schedule. All patients were monitored closely for signs and symptoms of hyperkalemia, e.g. dyspnoea, weakness, numbness, chest pain and cardiac manifestations (conduction abnormalities and cardiac arrhythmias). Other common adverse reactions during arginine/lysine solution administration are nausea and vomiting. Before the start of arginine/lysine solution infusion, an intravenous bolus of an anti-emetic was given. The choice of anti-emetic drugs was at the discretion of the physician. Follow-up Phase: All patients were called for a safety follow-up in 48 hours after dosing. Patients were not scheduled to receive repeat dosing with arginine/lysine solution as concomitant medication with Lutathera® within 7 days of the arginine/lysine solution infusion in the study.
Interventions
DRUGarginine/lysine
1000 milliliters (mL) administered at a constant rate of 250 mL per hour
Sponsors
Advanced Accelerator Applications
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs), who are eligible for the treatment with Lutathera as per Lutathera label indication. * Patients who have provided a signed informed consent form to participate in the study, obtained prior to the start of any protocol related procedures.
Exclusion criteria
* Pre-existing hyperkalemia (\>6.0 mmol/L at screening) if not adequately corrected before starting the LysaKare (arginine/lysine) infusion. For Poland only, pre-existing hyperkalemia (\> 5.5 mmol/L at screening) if not adequately corrected before starting the LysaKare (arginine/lysine) infusion. * Instances when Lutathera is not recommended per the Lutathera Summary of Product Characteristics (SmPC). * Pregnancy or lactation, positive pregnancy test at screening or pre-dose based on the contraindication for Lutathera. * Any significant medical or social condition which may interfere with the subject's ability to comply with the study visit schedule or the study assessments. * Patients who have received any investigational agent within the last 30 days. * Patients that have received a dose of Lutathera prior to the screening visit or are scheduled for Peptide Receptor Repeat (PRRT) treatment within 7 days of the study infusion of arginine/lysine solution. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Serum Potassium Levels Over 24 Hours | Day 0/Infusion Day (Hour 0, Hour 2, Hour 4, Hour 6, Hour 8, Hour 12, Hour 24) | Serum potassium levels at each collection time point will be measured at local laboratories of study sites using validated methods. The potassium concentration results will be summarized descriptively and will include mean change, maximum change, time to the maximum change, and the overall dynamics of the potassium concentration curve during and after the arginine/lysine infusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Notable Changes in Vital Signs | Day 0/Infusion Day (0, 2, 4, 6, 8, 12 and 24 hours) | Safety measured by the notable post-baseline changes in vital signs: (systolic blood pressure, diastolic blood pressure, pulse rate & weight) compared to baseline. |
| Number of Participants With Notable Changes in Electrocardiogram (ECG) | Day 0/Infusion Day (0, 4, 8 and 24 hours) | Safety measured by the notable post-baseline changes in ECG values compared to baseline PR, QRS, QT, QTcF, and RR intervals were obtained from 12-lead ECGs for each subject during the study |
| Number of Participants With Notable Changes in Hematology Parameters | Day 0/Infusion Day (0 and 24 hours) | Safety measured by the notable post-baseline changes in Hematology parameters compared to baseline as represented by Shift tables based on common toxicity criteria (CTC) grades. Each participant was counted only for the worst grade observed post-baseline. Notable change is the shift to higher grades from baseline. |
| Number of Participants With Notable Changes in Chemistry Parameters | Day 0/Infusion Day (0 and 24 hours) | Safety measured by the notable post-baseline changes in Chemistry parameters compared to baseline. Each participant was counted only for the worst grade observed post-baseline. Notable change is the shift to higher grades from baseline. Key shifts were in the following parameters: creatinine, lactate dehydrogenase and creatinine clearance. |
| Percentage of Participants With Treatment Adverse Events (AEs) & Serious Adverse Events (SAEs) | Day 0/Infusion Day up to 48 hours post infusion | Safety measured by the percentage of participants with treatment emergent adverse events (starting from the signing of the ICF until the end of the follow-up call (48 hours after infusion). |
| Mean Change From Baseline in Blood Gas Parameter, pH, Over 24 Hours | Day 0/Infusion Day (0, 2, 4, 6, 8, 12 and 24 hours) | Safety measured by the mean changes in blood gas compared to baseline. Blood gas parameter: pH. |
| Mean Change From Baseline in Blood Gas Parameter, Lactic Acid, Over 24 Hours | Day 0/Infusion Day (0, 2, 4, 6, 8, 12 and 24 hours) | Safety measured by the mean changes in blood gas compared to baseline. Blood gas parameter: Lactic Acid |
| Mean Change From Baseline in Blood Gas Parameter, Partial Pressure Carbon Dioxide, Over 24 Hours | Day 0/Infusion Day (0, 2, 4, 6, 8, 12 and 24 hours) | Safety measured by the mean changes in blood gas compared to baseline. Blood gas parameter: Partial Pressure Carbon Dioxide. |
| Number of Participants With Notable Changes in Electrolyte Parameters | Day 0/Infusion Day (0, 2, 4, 6, 8, 12 and 24 hours) | Safety measured by the notable post-baseline changes in Electrolyte parameters compared to baseline. Each participant was counted only for the worst grade observed post-baseline. Notable change is the shift to higher grades from baseline. |
Countries
Italy, Netherlands, Poland, United Kingdom
Participant flow
Recruitment details
A total of 42 participants were enrolled in 7 centers in 4 countries.
Pre-assignment details
The study schedule for each participant consisted of a screening period followed by an infusion day with an optional overnight in-clinic stay, and a follow-up call.
Participants by arm
| Arm | Count |
|---|---|
| GEP-NET One dose of arginine/lysine solution administered intravenously over a 4-hour period | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Subject Decision | 1 |
Baseline characteristics
| Characteristic | GEP-NET |
|---|---|
| Age, Continuous | 57.7 Years STANDARD_DEVIATION 9.46 |
| Race/Ethnicity, Customized Black or African American | 3 Participants |
| Race/Ethnicity, Customized White | 38 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 41 |
| other Total, other adverse events | 11 / 41 |
| serious Total, serious adverse events | 0 / 41 |
Outcome results
Primary
Mean Change From Baseline in Serum Potassium Levels Over 24 Hours
Serum potassium levels at each collection time point will be measured at local laboratories of study sites using validated methods. The potassium concentration results will be summarized descriptively and will include mean change, maximum change, time to the maximum change, and the overall dynamics of the potassium concentration curve during and after the arginine/lysine infusion.
Time frame: Day 0/Infusion Day (Hour 0, Hour 2, Hour 4, Hour 6, Hour 8, Hour 12, Hour 24)
Population: Evaluable Set: The Evaluable Set comprises all subjects who received any volume of the LysaKare infusion and provided both pre-dose and at least one post-dose (between 4 and 8 hours) potassium levels measured from serum.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GEP-NET | Mean Change From Baseline in Serum Potassium Levels Over 24 Hours | Pre-dose (hour 0) | 4.3 mmol/L | Standard Deviation 0.397 |
| GEP-NET | Mean Change From Baseline in Serum Potassium Levels Over 24 Hours | Change from Baseline (BL) to Hour 2 | 0.25 mmol/L | Standard Deviation 0.452 |
| GEP-NET | Mean Change From Baseline in Serum Potassium Levels Over 24 Hours | Change from Baseline (BL) to Hour 4 | 0.60 mmol/L | Standard Deviation 0.666 |
| GEP-NET | Mean Change From Baseline in Serum Potassium Levels Over 24 Hours | Change from Baseline (BL) to Hour 6 | 0.49 mmol/L | Standard Deviation 0.602 |
| GEP-NET | Mean Change From Baseline in Serum Potassium Levels Over 24 Hours | Change from Baseline (BL) to Hour 8 | 0.38 mmol/L | Standard Deviation 0.487 |
| GEP-NET | Mean Change From Baseline in Serum Potassium Levels Over 24 Hours | Change from Baseline (BL) to Hour 12 | 0.24 mmol/L | Standard Deviation 0.557 |
| GEP-NET | Mean Change From Baseline in Serum Potassium Levels Over 24 Hours | Change from Baseline (BL) to Hour 24 | 0.07 mmol/L | Standard Deviation 0.396 |
Secondary
Mean Change From Baseline in Blood Gas Parameter, Lactic Acid, Over 24 Hours
Safety measured by the mean changes in blood gas compared to baseline. Blood gas parameter: Lactic Acid
Time frame: Day 0/Infusion Day (0, 2, 4, 6, 8, 12 and 24 hours)
Population: Safety Set: The Safety Set (SAF) comprises all subjects who received any administration of the LysaKare infusion in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GEP-NET | Mean Change From Baseline in Blood Gas Parameter, Lactic Acid, Over 24 Hours | Day 0/Infusion Day (Pre-dose) (hour 0) | 1.40 mmol/L | Standard Deviation 0.604 |
| GEP-NET | Mean Change From Baseline in Blood Gas Parameter, Lactic Acid, Over 24 Hours | Change from Baseline (BL) to Hour 2 | -0.07 mmol/L | Standard Deviation 0.671 |
| GEP-NET | Mean Change From Baseline in Blood Gas Parameter, Lactic Acid, Over 24 Hours | Change from Baseline (BL) to Hour 4 | -0.23 mmol/L | Standard Deviation 0.523 |
| GEP-NET | Mean Change From Baseline in Blood Gas Parameter, Lactic Acid, Over 24 Hours | Change from Baseline (BL) to Hour 6 | -0.26 mmol/L | Standard Deviation 0.546 |
| GEP-NET | Mean Change From Baseline in Blood Gas Parameter, Lactic Acid, Over 24 Hours | Change from Baseline (BL) to Hour 8 | -0.19 mmol/L | Standard Deviation 0.465 |
| GEP-NET | Mean Change From Baseline in Blood Gas Parameter, Lactic Acid, Over 24 Hours | Change from Baseline (BL) to Hour 12 | -0.21 mmol/L | Standard Deviation 0.657 |
| GEP-NET | Mean Change From Baseline in Blood Gas Parameter, Lactic Acid, Over 24 Hours | Change from Baseline (BL) to Hour 24 | -0.16 mmol/L | Standard Deviation 0.65 |
Secondary
Mean Change From Baseline in Blood Gas Parameter, Partial Pressure Carbon Dioxide, Over 24 Hours
Safety measured by the mean changes in blood gas compared to baseline. Blood gas parameter: Partial Pressure Carbon Dioxide.
Time frame: Day 0/Infusion Day (0, 2, 4, 6, 8, 12 and 24 hours)
Population: Safety Set: The Safety Set (SAF) comprises all subjects who received any administration of the LysaKare infusion in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GEP-NET | Mean Change From Baseline in Blood Gas Parameter, Partial Pressure Carbon Dioxide, Over 24 Hours | Day 0/Infusion Day (Pre-dose) (hour 0) | 50.53 mmHg | Standard Deviation 8.712 |
| GEP-NET | Mean Change From Baseline in Blood Gas Parameter, Partial Pressure Carbon Dioxide, Over 24 Hours | Change from Baseline (BL) to Hour 2 | -1.08 mmHg | Standard Deviation 6.67 |
| GEP-NET | Mean Change From Baseline in Blood Gas Parameter, Partial Pressure Carbon Dioxide, Over 24 Hours | Change from Baseline (BL) to Hour 4 | -2.44 mmHg | Standard Deviation 8.717 |
| GEP-NET | Mean Change From Baseline in Blood Gas Parameter, Partial Pressure Carbon Dioxide, Over 24 Hours | Change from Baseline (BL) to Hour 6 | -4.90 mmHg | Standard Deviation 8.507 |
| GEP-NET | Mean Change From Baseline in Blood Gas Parameter, Partial Pressure Carbon Dioxide, Over 24 Hours | Change from Baseline (BL) to Hour 8 | -4.87 mmHg | Standard Deviation 8.399 |
| GEP-NET | Mean Change From Baseline in Blood Gas Parameter, Partial Pressure Carbon Dioxide, Over 24 Hours | Change from Baseline (BL) to Hour 12 | -5.71 mmHg | Standard Deviation 8.002 |
| GEP-NET | Mean Change From Baseline in Blood Gas Parameter, Partial Pressure Carbon Dioxide, Over 24 Hours | Change from Baseline (BL) to Hour 24 | -2.54 mmHg | Standard Deviation 8.242 |
Secondary
Mean Change From Baseline in Blood Gas Parameter, pH, Over 24 Hours
Safety measured by the mean changes in blood gas compared to baseline. Blood gas parameter: pH.
Time frame: Day 0/Infusion Day (0, 2, 4, 6, 8, 12 and 24 hours)
Population: Safety Set: The Safety Set (SAF) comprises all subjects who received any administration of the LysaKare infusion in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GEP-NET | Mean Change From Baseline in Blood Gas Parameter, pH, Over 24 Hours | Change from Baseline (BL) to Hour 2 | -0.03 unitless | Standard Deviation 0.046 |
| GEP-NET | Mean Change From Baseline in Blood Gas Parameter, pH, Over 24 Hours | Change from Baseline (BL) to Hour 4 | -0.06 unitless | Standard Deviation 0.055 |
| GEP-NET | Mean Change From Baseline in Blood Gas Parameter, pH, Over 24 Hours | Change from Baseline (BL) to Hour 6 | -0.05 unitless | Standard Deviation 0.051 |
| GEP-NET | Mean Change From Baseline in Blood Gas Parameter, pH, Over 24 Hours | Change from Baseline (BL) to Hour 8 | -0.05 unitless | Standard Deviation 0.056 |
| GEP-NET | Mean Change From Baseline in Blood Gas Parameter, pH, Over 24 Hours | Change from Baseline (BL) to Hour 12 | -0.03 unitless | Standard Deviation 0.054 |
| GEP-NET | Mean Change From Baseline in Blood Gas Parameter, pH, Over 24 Hours | Change from Baseline (BL) to Hour 24 | -0.04 unitless | Standard Deviation 0.051 |
| GEP-NET | Mean Change From Baseline in Blood Gas Parameter, pH, Over 24 Hours | Day 0/Infusion Day (Pre-dose) (hour 0) | 7.35 unitless | Standard Deviation 0.046 |
Secondary
Number of Participants With Notable Changes in Chemistry Parameters
Safety measured by the notable post-baseline changes in Chemistry parameters compared to baseline. Each participant was counted only for the worst grade observed post-baseline. Notable change is the shift to higher grades from baseline. Key shifts were in the following parameters: creatinine, lactate dehydrogenase and creatinine clearance.
Time frame: Day 0/Infusion Day (0 and 24 hours)
Population: Safety Set: The Safety Set (SAF) comprises all subjects who received any administration of the LysaKare infusion in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GEP-NET | Number of Participants With Notable Changes in Chemistry Parameters | Creatinine (increase) | 4 Participants |
| GEP-NET | Number of Participants With Notable Changes in Chemistry Parameters | Lactate dehydrogenase (increase) | 3 Participants |
| GEP-NET | Number of Participants With Notable Changes in Chemistry Parameters | Creatinine clearance (decrease) | 4 Participants |
Secondary
Number of Participants With Notable Changes in Electrocardiogram (ECG)
Safety measured by the notable post-baseline changes in ECG values compared to baseline PR, QRS, QT, QTcF, and RR intervals were obtained from 12-lead ECGs for each subject during the study
Time frame: Day 0/Infusion Day (0, 4, 8 and 24 hours)
Population: Safety Set: The Safety Set (SAF) comprises all subjects who received any administration of the LysaKare infusion in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GEP-NET | Number of Participants With Notable Changes in Electrocardiogram (ECG) | QTcF (ms): Increase >30 to ≤ 60 ms | 7 Participants |
| GEP-NET | Number of Participants With Notable Changes in Electrocardiogram (ECG) | QTcF (ms): Increase >60 ms | 0 Participants |
| GEP-NET | Number of Participants With Notable Changes in Electrocardiogram (ECG) | QTcF (ms): New >450 to ≤ 480 ms | 7 Participants |
| GEP-NET | Number of Participants With Notable Changes in Electrocardiogram (ECG) | QTcF (ms): New >480 to ≤ 500 ms | 0 Participants |
| GEP-NET | Number of Participants With Notable Changes in Electrocardiogram (ECG) | QTcF (ms); New >500 ms | 0 Participants |
| GEP-NET | Number of Participants With Notable Changes in Electrocardiogram (ECG) | QT (ms): Increase >30 to ≤ 60 ms | 9 Participants |
| GEP-NET | Number of Participants With Notable Changes in Electrocardiogram (ECG) | QT (ms): Increase >60 ms | 2 Participants |
| GEP-NET | Number of Participants With Notable Changes in Electrocardiogram (ECG) | QT (ms): New >450 to ≤ 480 ms | 6 Participants |
| GEP-NET | Number of Participants With Notable Changes in Electrocardiogram (ECG) | QT (ms): New >480 to ≤ 500 ms | 1 Participants |
| GEP-NET | Number of Participants With Notable Changes in Electrocardiogram (ECG) | QT (ms): New >500 ms | 0 Participants |
| GEP-NET | Number of Participants With Notable Changes in Electrocardiogram (ECG) | PR (ms): Increase >25% and PR >200 ms | 1 Participants |
| GEP-NET | Number of Participants With Notable Changes in Electrocardiogram (ECG) | PR (ms): New PR >200 ms | 6 Participants |
| GEP-NET | Number of Participants With Notable Changes in Electrocardiogram (ECG) | QRS (ms): Increase >25% and QRS >120 ms | 2 Participants |
| GEP-NET | Number of Participants With Notable Changes in Electrocardiogram (ECG) | QRS (ms): New QRS >120 ms | 2 Participants |
| GEP-NET | Number of Participants With Notable Changes in Electrocardiogram (ECG) | HR (bpm): Increase >25% and HR >100 bpm | 0 Participants |
| GEP-NET | Number of Participants With Notable Changes in Electrocardiogram (ECG) | HR (bpm): Decrease >25% and HR <50 bpm | 0 Participants |
Secondary
Number of Participants With Notable Changes in Electrolyte Parameters
Safety measured by the notable post-baseline changes in Electrolyte parameters compared to baseline. Each participant was counted only for the worst grade observed post-baseline. Notable change is the shift to higher grades from baseline.
Time frame: Day 0/Infusion Day (0, 2, 4, 6, 8, 12 and 24 hours)
Population: Safety Set: The Safety Set (SAF) comprises all subjects who received any administration of the LysaKare infusion in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GEP-NET | Number of Participants With Notable Changes in Electrolyte Parameters | For Potassium (increase) | 7 Participants |
| GEP-NET | Number of Participants With Notable Changes in Electrolyte Parameters | For sodium (decrease) | 12 Participants |
Secondary
Number of Participants With Notable Changes in Hematology Parameters
Safety measured by the notable post-baseline changes in Hematology parameters compared to baseline as represented by Shift tables based on common toxicity criteria (CTC) grades. Each participant was counted only for the worst grade observed post-baseline. Notable change is the shift to higher grades from baseline.
Time frame: Day 0/Infusion Day (0 and 24 hours)
Population: Safety Set: The Safety Set (SAF) comprises all subjects who received any administration of the LysaKare infusion in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GEP-NET | Number of Participants With Notable Changes in Hematology Parameters | 0 Participants |
Secondary
Number of Participants With Notable Changes in Vital Signs
Safety measured by the notable post-baseline changes in vital signs: (systolic blood pressure, diastolic blood pressure, pulse rate & weight) compared to baseline.
Time frame: Day 0/Infusion Day (0, 2, 4, 6, 8, 12 and 24 hours)
Population: The Safety Set (SAF) comprises all subjects who received any administration of the LysaKare infusion in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GEP-NET | Number of Participants With Notable Changes in Vital Signs | Systolic blood pressure (mmHg): ≥180 with increase from baseline of ≥20 | 0 Participants |
| GEP-NET | Number of Participants With Notable Changes in Vital Signs | Systolic blood pressure (mmHg): ≤ 90 with decrease from baseline of ≥20 | 0 Participants |
| GEP-NET | Number of Participants With Notable Changes in Vital Signs | Diastolic blood pressure (mmHg): ≥105 with increase from baseline of ≥15 | 0 Participants |
| GEP-NET | Number of Participants With Notable Changes in Vital Signs | Diastolic blood pressure (mmHg): ≤ 50 with decrease from baseline of ≥15 | 0 Participants |
| GEP-NET | Number of Participants With Notable Changes in Vital Signs | Pulse rate (bpm): ≥100 with increase from baseline of >25% | 0 Participants |
| GEP-NET | Number of Participants With Notable Changes in Vital Signs | Pulse rate (bpm): ≤ 50 with decrease from baseline of > 25% | 0 Participants |
| GEP-NET | Number of Participants With Notable Changes in Vital Signs | Weight (kg): increase ≥10% from Baseline | 0 Participants |
| GEP-NET | Number of Participants With Notable Changes in Vital Signs | Weight (kg): decrease > 10% from Baseline | 0 Participants |
Secondary
Percentage of Participants With Treatment Adverse Events (AEs) & Serious Adverse Events (SAEs)
Safety measured by the percentage of participants with treatment emergent adverse events (starting from the signing of the ICF until the end of the follow-up call (48 hours after infusion).
Time frame: Day 0/Infusion Day up to 48 hours post infusion
Population: Safety Set: The Safety Set (SAF) comprises all subjects who received any administration of the LysaKare infusion in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GEP-NET | Percentage of Participants With Treatment Adverse Events (AEs) & Serious Adverse Events (SAEs) | Adverse Event (AEs) | 11 Participants |
| GEP-NET | Percentage of Participants With Treatment Adverse Events (AEs) & Serious Adverse Events (SAEs) | Treatment-related AEs | 6 Participants |
| GEP-NET | Percentage of Participants With Treatment Adverse Events (AEs) & Serious Adverse Events (SAEs) | Serious Adverse Events (SAEs) | 0 Participants |
| GEP-NET | Percentage of Participants With Treatment Adverse Events (AEs) & Serious Adverse Events (SAEs) | Fatal SAEs | 0 Participants |
| GEP-NET | Percentage of Participants With Treatment Adverse Events (AEs) & Serious Adverse Events (SAEs) | AEs leading to discontinuation | 0 Participants |
| GEP-NET | Percentage of Participants With Treatment Adverse Events (AEs) & Serious Adverse Events (SAEs) | AEs leading to Interrruption | 0 Participants |
| GEP-NET | Percentage of Participants With Treatment Adverse Events (AEs) & Serious Adverse Events (SAEs) | AEs requiring additional therapy | 5 Participants |
| GEP-NET | Percentage of Participants With Treatment Adverse Events (AEs) & Serious Adverse Events (SAEs) | Treatment related AEs req. additional therapy | 3 Participants |