NCT02347917 · OUTCOME
Phase 1 Part: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Drug Reactions (ADRs)
A Study of BBI608 in Combination With Pemetrexed and Cisplatin in Adult Patients With Malignant Pleural Mesothelioma · Source last updated 2022-04-12
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
- Between initial dosing of the investigational drug and final evaluation in the follow-up observation period, about 17 months
What was measured
An AE is any untoward medical occurrence in a study subject administered an investigational drug and which does not necessarily have a causal relationship with this treatment.
A SAE was an AE that met one or more of the following criteria:
* Results in death
* Is life-threatening
* Requires hospitalization or prolongation of existing hospitalization
* Results in persistent or significant disability or incapacity
* Is a congenital anomaly or birth defect
* Is an important medical event that may jeopardize the subject or may require a medical or surgical intervention to prevent one of the outcomes listed above. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization.
An ADR was defined as adverse events assessed to be related to the investigational drug
Analysis population: Safety analysis populations (Phase 1 part)
Groups in this outcome
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles.
Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) | 4 |
|---|
Reported measurements
Any AEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
AEs leading to death
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Serious AEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
AEs leading to drug withdrawn (BBI608)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
AEs leading to drug interrupted (BBI608)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
AEs leading to dose reduced (BBI608)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Any ADRs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
ADRs leading to death
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Serious ADRs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
ADRs leading to drug withdrawn (BBI608)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
ADRs leading to drug interrupted (BBI608)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
ADRs leading to dose reduced (BBI608)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- title
- Any AEs
- title
- AEs leading to death
- title
- Serious AEs
- title
- AEs leading to drug withdrawn (BBI608)
- title
- AEs leading to drug interrupted (BBI608)
- title
- AEs leading to dose reduced (BBI608)
- title
- Any ADRs
- title
- ADRs leading to death
- title
- Serious ADRs
- title
- ADRs leading to drug withdrawn (BBI608)
- title
- ADRs leading to drug interrupted (BBI608)
- title
- ADRs leading to dose reduced (BBI608)
- description
- An AE is any untoward medical occurrence in a study subject administered an investigational drug and which does not necessarily have a causal relationship with this treatment.
A SAE was an AE that met one or more of the following criteria:
* Results in death
* Is life-threatening
* Requires hospitalization or prolongation of existing hospitalization
* Results in persistent or significant disability or incapacity
* Is a congenital anomaly or birth defect
* Is an important medical event that may jeopardize the subject or may require a medical or surgical intervention to prevent one of the outcomes listed above. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization.
An ADR was defined as adverse events assessed to be related to the investigational drug
- groups
- description
- Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles.
Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.
- id
- OG000
- title
- MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis populations (Phase 1 part)
- reporting Status
- POSTED
- time Frame
- Between initial dosing of the investigational drug and final evaluation in the follow-up observation period, about 17 months
- title
- Phase 1 Part: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Drug Reactions (ADRs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle