TriangleNCT01624090 · OUTCOME
Number of Participants With Serious and Non-Serious 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
- Date treatment consent signed to date off study, approx. 9 mos & 6 days DL1 30 mcg/kg thoracic group, 2 mos & 16 days DL1 30 mcg/kg extra-thoracic group, 5 mos & 26 days DL-1 25 mcg/kg thoracic group, & 20 days DL-1 25 mcg/kg extra-thoracic group
What was measured
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Analysis population: One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.
Groups in this outcome
Dose Level 1 - 30 mcg/kg Thoracic Malignancy
Single agent intravenous (IV) mithramycin Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.
Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy
Single agent intravenous (IV) mithramycin Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.
Dose Level -1 - 25 mcg/kg Thoracic Malignancy
Single agent intravenous (IV) mithramycin Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).
Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy
Single agent intravenous (IV) mithramycin Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).
| Group | Source count |
|---|---|
| Dose Level 1 - 30 mcg/kg Thoracic Malignancy | 2 |
| Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy | 1 |
| Dose Level -1 - 25 mcg/kg Thoracic Malignancy | 10 |
| Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 - 30 mcg/kg Thoracic Malignancy | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level -1 - 25 mcg/kg Thoracic Malignancy | 10 | Not reported | Not reported | Not reported | Not reported |
| Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 2
- units
- Participants
- description
- Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
- groups
- description
- Single agent intravenous (IV) mithramycin Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Dose Level 1 - 30 mcg/kg Thoracic Malignancy
- description
- Single agent intravenous (IV) mithramycin Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.
- id
- OG001
- title
- Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy
- description
- Single agent intravenous (IV) mithramycin Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).
- id
- OG002
- title
- Dose Level -1 - 25 mcg/kg Thoracic Malignancy
- description
- Single agent intravenous (IV) mithramycin Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).
- id
- OG003
- title
- Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.
- reporting Status
- POSTED
- time Frame
- Date treatment consent signed to date off study, approx. 9 mos & 6 days DL1 30 mcg/kg thoracic group, 2 mos & 16 days DL1 30 mcg/kg extra-thoracic group, 5 mos & 26 days DL-1 25 mcg/kg thoracic group, & 20 days DL-1 25 mcg/kg extra-thoracic group
- title
- Number of Participants With Serious and Non-Serious Adverse Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice