TriangleNCT00586924 · OUTCOME
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
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 start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
What was measured
Vital signs abnormalities reported as TEAEs included pyrexia, weight increased, dyspnoea, hypoxia, hypertension, hypotension.
Analysis population: Safety population included all participants who received any treatment of moxetumomab pasudotox.
Groups in this outcome
5 mcg/kg
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
10 mcg/kg
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
20 mcg/kg
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
30 mcg/kg
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
40 mcg/kg
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
50 mcg/kg
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
| Group | Source count |
|---|---|
| 5 mcg/kg | 3 |
| 10 mcg/kg | 3 |
| 20 mcg/kg | 3 |
| 30 mcg/kg | 3 |
| 40 mcg/kg | 4 |
| 50 mcg/kg | 33 |
Reported measurements
Pyrexia
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 5 mcg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| 10 mcg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| 20 mcg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| 30 mcg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| 40 mcg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| 50 mcg/kg | 16 | Not reported | Not reported | Not reported | Not reported |
Weight increased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 5 mcg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| 10 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 20 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 30 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 40 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 50 mcg/kg | 6 | Not reported | Not reported | Not reported | Not reported |
Dyspnoea
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 5 mcg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| 10 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 20 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 30 mcg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| 40 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 50 mcg/kg | 6 | Not reported | Not reported | Not reported | Not reported |
Hypoxia
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 5 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 10 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 20 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 30 mcg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| 40 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 50 mcg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
Hypertension
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 5 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 10 mcg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| 20 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 30 mcg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| 40 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 50 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Hypotension
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 5 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 10 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 20 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 30 mcg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| 40 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 50 mcg/kg | 10 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 16
- title
- Pyrexia
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 6
- title
- Weight increased
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 6
- title
- Dyspnoea
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- title
- Hypoxia
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Hypertension
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 10
- title
- Hypotension
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 33
- units
- Participants
- description
- Vital signs abnormalities reported as TEAEs included pyrexia, weight increased, dyspnoea, hypoxia, hypertension, hypotension.
- groups
- description
- Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
- id
- OG000
- title
- 5 mcg/kg
- description
- Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
- id
- OG001
- title
- 10 mcg/kg
- description
- Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
- id
- OG002
- title
- 20 mcg/kg
- description
- Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
- id
- OG003
- title
- 30 mcg/kg
- description
- Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
- id
- OG004
- title
- 40 mcg/kg
- description
- Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
- id
- OG005
- title
- 50 mcg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety population included all participants who received any treatment of moxetumomab pasudotox.
- reporting Status
- POSTED
- time Frame
- From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
- title
- Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
- type
- PRIMARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice