TriangleNCT00426764 · 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
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. Mean duration of treatment up until 30 September 2012 (data cutoff for analysis) was 169 days.
What was measured
An adverse event or experience (AE) is defined as any untoward medical occurrence, which does not necessarily have to have a causal relationship with this treatment. A serious AE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event or condition. Related AEs are defined as those considered by the Investigator to have a possible, probable, or very likely/certain relationship to the study drug. AEs were graded as mild (1), moderate (2), severe (3), lifethreatening (4), or death (5). TEAEs occurred from the first dose of study medication through the end of the study (30 days post last dose) or any event that was present at baseline but worsened in intensity or was subsequently considered drug-related by the Investigator through end of study.
Analysis population: Safety Population: all participants who received at least 1 dose of romidepsin.
Groups in this outcome
Romidepsin
Participants received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
| Group | Source count |
|---|---|
| Romidepsin | 131 |
Reported measurements
TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Romidepsin | 128 | Not reported | Not reported | Not reported | Not reported |
≥ Grade 3 TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Romidepsin | 89 | Not reported | Not reported | Not reported | Not reported |
≥ Grade 4 TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Romidepsin | 27 | Not reported | Not reported | Not reported | Not reported |
Serious TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Romidepsin | 61 | Not reported | Not reported | Not reported | Not reported |
TEAE Leading to Discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Romidepsin | 25 | Not reported | Not reported | Not reported | Not reported |
Deaths within 30 days of Last Dose
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Romidepsin | 8 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 128
- title
- TEAE
- categories
- measurements
- group Id
- OG000
- value
- 89
- title
- ≥ Grade 3 TEAE
- categories
- measurements
- group Id
- OG000
- value
- 27
- title
- ≥ Grade 4 TEAE
- categories
- measurements
- group Id
- OG000
- value
- 61
- title
- Serious TEAE
- categories
- measurements
- group Id
- OG000
- value
- 25
- title
- TEAE Leading to Discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 8
- title
- Deaths within 30 days of Last Dose
- denoms
- counts
- group Id
- OG000
- value
- 131
- units
- Participants
- description
- An adverse event or experience (AE) is defined as any untoward medical occurrence, which does not necessarily have to have a causal relationship with this treatment. A serious AE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event or condition. Related AEs are defined as those considered by the Investigator to have a possible, probable, or very likely/certain relationship to the study drug. AEs were graded as mild (1), moderate (2), severe (3), lifethreatening (4), or death (5). TEAEs occurred from the first dose of study medication through the end of the study (30 days post last dose) or any event that was present at baseline but worsened in intensity or was subsequently considered drug-related by the Investigator through end of study.
- groups
- description
- Participants received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
- id
- OG000
- title
- Romidepsin
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Population: all participants who received at least 1 dose of romidepsin.
- reporting Status
- POSTED
- time Frame
- From first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. Mean duration of treatment up until 30 September 2012 (data cutoff for analysis) was 169 days.
- title
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice