TriangleNCT04711135 · OUTCOME
Incidence of Adverse Events (AEs) During Treatment and Short-term Follow-up
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From first Lutetium [Lu 177] dotatate dose to 6 months after last dose, approx. 12 months
What was measured
Cumulative safety of Lutathera in adolescents with SSTR-positive GEP-NETs and PPGLs as a pooled cohort was assessed through the incidence of adverse events (AEs) and laboratory toxicities until 6 months after the last Lutathera dose.
Analysis population: Safety Set: The Safety Set included all participants that received at least one dose of Lutathera.
Groups in this outcome
GEP-NET
All eligible participants with Gastroenteropancreatic neuroendocrine tumor (GEP-NET) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.
PPGL
All eligible participants with Pheochromocytoma and paraganglioma (PPGL) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.
| Group | Source count |
|---|---|
| GEP-NET | 4 |
| PPGL | 7 |
Reported measurements
AEs during Lutathera treatment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| GEP-NET | 4 | Not reported | Not reported | Not reported | Not reported |
| PPGL | 7 | Not reported | Not reported | Not reported | Not reported |
AEs during short-term follow-up
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| GEP-NET | 1 | Not reported | Not reported | Not reported | Not reported |
| PPGL | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 7
- title
- AEs during Lutathera treatment
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- title
- AEs during short-term follow-up
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 7
- units
- Participants
- description
- Cumulative safety of Lutathera in adolescents with SSTR-positive GEP-NETs and PPGLs as a pooled cohort was assessed through the incidence of adverse events (AEs) and laboratory toxicities until 6 months after the last Lutathera dose.
- groups
- description
- All eligible participants with Gastroenteropancreatic neuroendocrine tumor (GEP-NET) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.
- id
- OG000
- title
- GEP-NET
- description
- All eligible participants with Pheochromocytoma and paraganglioma (PPGL) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.
- id
- OG001
- title
- PPGL
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Set: The Safety Set included all participants that received at least one dose of Lutathera.
- reporting Status
- POSTED
- time Frame
- From first Lutetium [Lu 177] dotatate dose to 6 months after last dose, approx. 12 months
- title
- Incidence of Adverse Events (AEs) During Treatment and Short-term Follow-up
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice