TriangleNCT00586924 · OUTCOME
Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities Recorded as Adverse Events (AEs)
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
Cardiac AEs observed in participants with clinically significant ECG abnormalities included; ECG QT prolonged, Sinus tachycardia and Atrioventricular block first degree.
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
ECG QT prolonged
| 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 | 2 | Not reported | Not reported | Not reported | Not reported |
| 40 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 50 mcg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
Sinus tachycardia
| 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 | 2 | Not reported | Not reported | Not reported | Not reported |
Atrioventricular block first degree
| 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 | 0 | Not reported | Not reported | Not reported | Not reported |
| 40 mcg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| 50 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- title
- ECG QT prolonged
- 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
- 2
- title
- Sinus tachycardia
- 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
- group Id
- OG005
- value
- 0
- title
- Atrioventricular block first degree
- 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
- Cardiac AEs observed in participants with clinically significant ECG abnormalities included; ECG QT prolonged, Sinus tachycardia and Atrioventricular block first degree.
- 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 Clinically Relevant Electrocardiogram (ECG) Abnormalities Recorded as Adverse Events (AEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice