TriangleNCT01578239 · OUTCOME
Number of Participants With Adverse Events
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 informed consent signature through study completion reached at final safety cutoff date on 18July2021, assessed up to approximately 101 Months
What was measured
The distribution of adverse events was done via the analysis of frequencies for Adverse Event (AEs), Serious Adverse Event (SAEs) and Deaths, through the monitoring of relevant clinical and laboratory safety parameters.
Analysis population: Safety Analysis Set (SAF).
Groups in this outcome
177Lu-DOTA0-Tyr3-Octreotate
* 30 mg Octreotide LAR treatment for symptom control continued until the end of study, unless the participant progressed or died. * Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate: Four administrations of 7.4 GBq (200 mCi). * Concomitant amino acids were given with each administration for kidney protection. * 177Lu-DOTA0-Tyr3-Octreotate was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed.
Octreotide LAR
* 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed.
| Group | Source count |
|---|---|
| 177Lu-DOTA0-Tyr3-Octreotate | 111 |
| Octreotide LAR | 112 |
Reported measurements
Adverse Events (AEs)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 177Lu-DOTA0-Tyr3-Octreotate | 105 | Not reported | Not reported | Not reported | Not reported |
| Octreotide LAR | 90 | Not reported | Not reported | Not reported | Not reported |
Serious Adverse Events (SAEs)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 177Lu-DOTA0-Tyr3-Octreotate | 40 | Not reported | Not reported | Not reported | Not reported |
| Octreotide LAR | 31 | Not reported | Not reported | Not reported | Not reported |
Deaths during treatment period
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 177Lu-DOTA0-Tyr3-Octreotate | 4 | Not reported | Not reported | Not reported | Not reported |
| Octreotide LAR | 5 | Not reported | Not reported | Not reported | Not reported |
Deaths during follow-up period
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 177Lu-DOTA0-Tyr3-Octreotate | 66 | Not reported | Not reported | Not reported | Not reported |
| Octreotide LAR | 63 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 105
- group Id
- OG001
- value
- 90
- title
- Adverse Events (AEs)
- categories
- measurements
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 31
- title
- Serious Adverse Events (SAEs)
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- title
- Deaths during treatment period
- categories
- measurements
- group Id
- OG000
- value
- 66
- group Id
- OG001
- value
- 63
- title
- Deaths during follow-up period
- denoms
- counts
- group Id
- OG000
- value
- 111
- group Id
- OG001
- value
- 112
- units
- Participants
- description
- The distribution of adverse events was done via the analysis of frequencies for Adverse Event (AEs), Serious Adverse Event (SAEs) and Deaths, through the monitoring of relevant clinical and laboratory safety parameters.
- groups
- description
- * 30 mg Octreotide LAR treatment for symptom control continued until the end of study, unless the participant progressed or died. * Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate: Four administrations of 7.4 GBq (200 mCi). * Concomitant amino acids were given with each administration for kidney protection. * 177Lu-DOTA0-Tyr3-Octreotate was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed.
- id
- OG000
- title
- 177Lu-DOTA0-Tyr3-Octreotate
- description
- * 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed.
- id
- OG001
- title
- Octreotide LAR
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Analysis Set (SAF).
- reporting Status
- POSTED
- time Frame
- From informed consent signature through study completion reached at final safety cutoff date on 18July2021, assessed up to approximately 101 Months
- title
- Number of Participants With Adverse Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice