TriangleNCT02598661 · OUTCOME
Phase 2 and Phase 3: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Deaths
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
- Adverse events: Up to 5 years in Phase 2 and up to 3.7 years in Phase 3; Deaths: Up to 6.6 years in Phase 2 and up to 4 years in Phase 3
What was measured
TEAEs were defined as those events that 1) occurred after the first dose of study drug, through the treatment phase, and for 30 days following the last dose of study drug or until subsequent anti-cancer therapy if earlier; 2) any event that was considered study drug-related regardless of the start date of the event; or 3) any event that was presented at baseline but worsened in severity or was subsequently considered drug-related by the investigator. Serious TEAEs are any TEAEs that result 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 a suspected transmission of any infectious agent via a medicinal product, is medically important. Any clinically significant vital sign measurements, clinical laboratory values, and electrocardiogram (ECG) findings were reported as TEAEs. TEAEs included both serious and non-serious TEAEs.
Analysis population: Phase 2 and Phase 3: Safety Analysis Set included all participants who received at least one dose of study drug.
Groups in this outcome
Phase 2: Imetelstat Sodium (No Dose Escalation)
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 2: Imetelstat Sodium (Escalated to 9.4 mg/kg)
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) with dose escalation to 9.4 mg/kg allowed before Protocol Amendment 2, until death, lost to follow up, withdrawal of consent, or study termination, whichever occurs first.
Phase 3: Imetelstat Sodium
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
| Group | Source count |
|---|---|
| Phase 2: Imetelstat Sodium (No Dose Escalation) | 50 |
| Phase 2: Imetelstat Sodium (Escalated to 9.4 mg/kg) | 7 |
| Phase 3: Imetelstat Sodium | 118 |
| Phase 3: Placebo | 59 |
Reported measurements
Participants with AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Imetelstat Sodium (No Dose Escalation) | 50 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Imetelstat Sodium (Escalated to 9.4 mg/kg) | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 3: Imetelstat Sodium | 117 | Not reported | Not reported | Not reported | Not reported |
| Phase 3: Placebo | 59 | Not reported | Not reported | Not reported | Not reported |
Participants who died
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Imetelstat Sodium (No Dose Escalation) | 24 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Imetelstat Sodium (Escalated to 9.4 mg/kg) | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 3: Imetelstat Sodium | 35 | Not reported | Not reported | Not reported | Not reported |
| Phase 3: Placebo | 15 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 50
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 117
- group Id
- OG003
- value
- 59
- title
- Participants with AEs
- categories
- measurements
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 35
- group Id
- OG003
- value
- 15
- title
- Participants who died
- denoms
- counts
- group Id
- OG000
- value
- 50
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 118
- group Id
- OG003
- value
- 59
- units
- Participants
- description
- TEAEs were defined as those events that 1) occurred after the first dose of study drug, through the treatment phase, and for 30 days following the last dose of study drug or until subsequent anti-cancer therapy if earlier; 2) any event that was considered study drug-related regardless of the start date of the event; or 3) any event that was presented at baseline but worsened in severity or was subsequently considered drug-related by the investigator. Serious TEAEs are any TEAEs that result 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 a suspected transmission of any infectious agent via a medicinal product, is medically important. Any clinically significant vital sign measurements, clinical laboratory values, and electrocardiogram (ECG) findings were reported as TEAEs. TEAEs included both serious and non-serious TEAEs.
- groups
- description
- Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
- id
- OG000
- title
- Phase 2: Imetelstat Sodium (No Dose Escalation)
- description
- Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) with dose escalation to 9.4 mg/kg allowed before Protocol Amendment 2, until death, lost to follow up, withdrawal of consent, or study termination, whichever occurs first.
- id
- OG001
- title
- Phase 2: Imetelstat Sodium (Escalated to 9.4 mg/kg)
- description
- Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
- id
- OG002
- title
- Phase 3: Imetelstat Sodium
- description
- Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
- id
- OG003
- title
- Phase 3: Placebo
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Phase 2 and Phase 3: Safety Analysis Set included all participants who received at least one dose of study drug.
- reporting Status
- POSTED
- time Frame
- Adverse events: Up to 5 years in Phase 2 and up to 3.7 years in Phase 3; Deaths: Up to 6.6 years in Phase 2 and up to 4 years in Phase 3
- title
- Phase 2 and Phase 3: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Deaths
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice