TriangleNCT00623831 · OUTCOME
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 3 months
What was measured
Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs from pre-treatment through 4 weeks after the last dose of study treatment.
Analysis population: The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.
Groups in this outcome
Cohort 1 (Safety Analysis Set)
Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
Cohort 2 (Safety Analysis Set)
Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU \[dose level 6\]) that was determined to be the pyrogenic dose level in Cohort 1.
| Group | Source count |
|---|---|
| Cohort 1 (Safety Analysis Set) | 13 |
| Cohort 2 (Safety Analysis Set) | 4 |
Reported measurements
Any TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 (Safety Analysis Set) | 13 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 (Safety Analysis Set) | 4 | Not reported | Not reported | Not reported | Not reported |
Grade 3 TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 (Safety Analysis Set) | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 (Safety Analysis Set) | 2 | Not reported | Not reported | Not reported | Not reported |
Grade 4 TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 (Safety Analysis Set) | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 (Safety Analysis Set) | 0 | Not reported | Not reported | Not reported | Not reported |
Grade 5 TEAE (Death)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 (Safety Analysis Set) | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 (Safety Analysis Set) | 0 | Not reported | Not reported | Not reported | Not reported |
Treatment-related TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 (Safety Analysis Set) | 9 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 (Safety Analysis Set) | 3 | Not reported | Not reported | Not reported | Not reported |
SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 (Safety Analysis Set) | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 (Safety Analysis Set) | 1 | Not reported | Not reported | Not reported | Not reported |
TEAE leading to withdrawal
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 (Safety Analysis Set) | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 (Safety Analysis Set) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 4
- title
- Any TEAE
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- title
- Grade 3 TEAE
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 4 TEAE
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Grade 5 TEAE (Death)
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 3
- title
- Treatment-related TEAE
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- title
- SAE
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- TEAE leading to withdrawal
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 4
- units
- Participants
- description
- Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs from pre-treatment through 4 weeks after the last dose of study treatment.
- groups
- description
- Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
- id
- OG000
- title
- Cohort 1 (Safety Analysis Set)
- description
- Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU \[dose level 6\]) that was determined to be the pyrogenic dose level in Cohort 1.
- id
- OG001
- title
- Cohort 2 (Safety Analysis Set)
- param Type
- NUMBER
- population Description
- The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- Up to 3 months
- title
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice