TriangleNCT03724253 · OUTCOME
Treatment Emergent Adverse Events Profile
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 dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
What was measured
Treatment-emergent adverse events (TEAEs) were collected from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent. The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Grade 3/4/5 TEAEs, Serious Adverse Event TEAEs, Interruption of \[68Ga\]-NeoBOMB1 Due to Any TEAEs and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
Analysis population: Full Analysis Set (FAS)
Groups in this outcome
Breast
All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Prostate
All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Colorectal
All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Non-Small Cell Lung Cancer (NSCLC)
All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Small-Cell Lung Cancer (SCLC)
All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
| Group | Source count |
|---|---|
| Breast | 5 |
| Prostate | 5 |
| Colorectal | 5 |
| Non-Small Cell Lung Cancer (NSCLC) | 3 |
| Small-Cell Lung Cancer (SCLC) | 1 |
Reported measurements
Treatment-Emergent Adverse Events (TEAEs)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Breast | 0 | Not reported | Not reported | Not reported | Not reported |
| Prostate | 1 | Not reported | Not reported | Not reported | Not reported |
| Colorectal | 3 | Not reported | Not reported | Not reported | Not reported |
| Non-Small Cell Lung Cancer (NSCLC) | 3 | Not reported | Not reported | Not reported | Not reported |
| Small-Cell Lung Cancer (SCLC) | 1 | Not reported | Not reported | Not reported | Not reported |
IMP-Related TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Breast | 0 | Not reported | Not reported | Not reported | Not reported |
| Prostate | 0 | Not reported | Not reported | Not reported | Not reported |
| Colorectal | 0 | Not reported | Not reported | Not reported | Not reported |
| Non-Small Cell Lung Cancer (NSCLC) | 0 | Not reported | Not reported | Not reported | Not reported |
| Small-Cell Lung Cancer (SCLC) | 0 | Not reported | Not reported | Not reported | Not reported |
Grade 3/4/5 TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Breast | 0 | Not reported | Not reported | Not reported | Not reported |
| Prostate | 0 | Not reported | Not reported | Not reported | Not reported |
| Colorectal | 0 | Not reported | Not reported | Not reported | Not reported |
| Non-Small Cell Lung Cancer (NSCLC) | 0 | Not reported | Not reported | Not reported | Not reported |
| Small-Cell Lung Cancer (SCLC) | 1 | Not reported | Not reported | Not reported | Not reported |
IMP-Related Grade 3/4/5 TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Breast | 0 | Not reported | Not reported | Not reported | Not reported |
| Prostate | 0 | Not reported | Not reported | Not reported | Not reported |
| Colorectal | 0 | Not reported | Not reported | Not reported | Not reported |
| Non-Small Cell Lung Cancer (NSCLC) | 0 | Not reported | Not reported | Not reported | Not reported |
| Small-Cell Lung Cancer (SCLC) | 0 | Not reported | Not reported | Not reported | Not reported |
Serious TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Breast | 0 | Not reported | Not reported | Not reported | Not reported |
| Prostate | 0 | Not reported | Not reported | Not reported | Not reported |
| Colorectal | 0 | Not reported | Not reported | Not reported | Not reported |
| Non-Small Cell Lung Cancer (NSCLC) | 0 | Not reported | Not reported | Not reported | Not reported |
| Small-Cell Lung Cancer (SCLC) | 1 | Not reported | Not reported | Not reported | Not reported |
IMP-Related Serious TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Breast | 0 | Not reported | Not reported | Not reported | Not reported |
| Prostate | 0 | Not reported | Not reported | Not reported | Not reported |
| Colorectal | 0 | Not reported | Not reported | Not reported | Not reported |
| Non-Small Cell Lung Cancer (NSCLC) | 0 | Not reported | Not reported | Not reported | Not reported |
| Small-Cell Lung Cancer (SCLC) | 0 | Not reported | Not reported | Not reported | Not reported |
TEAEs Interruption of [68Ga]-NeoBOMB1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Breast | 0 | Not reported | Not reported | Not reported | Not reported |
| Prostate | 0 | Not reported | Not reported | Not reported | Not reported |
| Colorectal | 0 | Not reported | Not reported | Not reported | Not reported |
| Non-Small Cell Lung Cancer (NSCLC) | 0 | Not reported | Not reported | Not reported | Not reported |
| Small-Cell Lung Cancer (SCLC) | 0 | Not reported | Not reported | Not reported | Not reported |
IMP-Related TEAEs Interruption of [68Ga]-NeoBOMB1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Breast | 0 | Not reported | Not reported | Not reported | Not reported |
| Prostate | 0 | Not reported | Not reported | Not reported | Not reported |
| Colorectal | 0 | Not reported | Not reported | Not reported | Not reported |
| Non-Small Cell Lung Cancer (NSCLC) | 0 | Not reported | Not reported | Not reported | Not reported |
| Small-Cell Lung Cancer (SCLC) | 0 | Not reported | Not reported | Not reported | Not reported |
Deaths Due to AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Breast | 0 | Not reported | Not reported | Not reported | Not reported |
| Prostate | 0 | Not reported | Not reported | Not reported | Not reported |
| Colorectal | 0 | Not reported | Not reported | Not reported | Not reported |
| Non-Small Cell Lung Cancer (NSCLC) | 0 | Not reported | Not reported | Not reported | Not reported |
| Small-Cell Lung Cancer (SCLC) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 1
- title
- Treatment-Emergent Adverse Events (TEAEs)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- IMP-Related TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- title
- Grade 3/4/5 TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- IMP-Related Grade 3/4/5 TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- title
- Serious TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- IMP-Related Serious TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- TEAEs Interruption of [68Ga]-NeoBOMB1
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- IMP-Related TEAEs Interruption of [68Ga]-NeoBOMB1
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Deaths Due to AEs
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 1
- units
- Participants
- description
- Treatment-emergent adverse events (TEAEs) were collected from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent. The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Grade 3/4/5 TEAEs, Serious Adverse Event TEAEs, Interruption of \[68Ga\]-NeoBOMB1 Due to Any TEAEs and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
- groups
- description
- All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
- id
- OG000
- title
- Breast
- description
- All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
- id
- OG001
- title
- Prostate
- description
- All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
- id
- OG002
- title
- Colorectal
- description
- All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
- id
- OG003
- title
- Non-Small Cell Lung Cancer (NSCLC)
- description
- All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
- id
- OG004
- title
- Small-Cell Lung Cancer (SCLC)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Full Analysis Set (FAS)
- reporting Status
- POSTED
- time Frame
- From first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
- title
- Treatment Emergent Adverse Events Profile
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice