NCT02860286 · OUTCOME
Incidence of Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Study of the EZH2 Inhibitor Tazemetostat in Malignant Mesothelioma · Source last updated 2021-04-09
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 the first dose of study treatment until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy.
Groups in this outcome
Part 1
Subjects with relapsed orrefractory malignantmesothelioma regardless ofBAP1 status were to be treatedand PK blood samplescollected after a singletazemetostat 800 mg dose onCycle 1 Day 1 and afterrepeated twice daily doses oftazemetostat 800 mg on Cycle1 Day 15. Subjects were toreceive a single oral 800 mgtazemetostat dose on Cycle 1Day 1. Starting on Cycle 1 Day2, tazemetostat was orallyadministered at a dose of 800mg twice daily.
Part 2
Subjects with BAP1-deficientrelapsed or refractorymalignant mesothelioma wereto receive orally administeredtazemetostat 800 mg twicedaily starting on Cycle 1 Day1
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 |
|---|
| Part 1 | 13 |
|---|
| Part 2 | 61 |
|---|
Reported measurements
Any TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2 | 60 | Not reported | Not reported | Not reported | Not reported |
|---|
Any TEAE Grade 3 or 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2 | 31 | Not reported | Not reported | Not reported | Not reported |
|---|
Any Treatment-Related TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2 | 44 | Not reported | Not reported | Not reported | Not reported |
|---|
Any Treatment-Related TEAE Grade 3 or 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2 | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
Any TEAE Leading to Dose Reduction or 4or() {
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Any TEAE Leading to Study Drug Interruption��
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2 | 22 | Not reported | Not reported | Not reported | Not reported |
|---|
Any TEAE Leading to Study Drug Discontinuation
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Any TESAENR
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2 | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
Any Treatment-Related TESAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Any Protocol Defined AE of Special Interestion
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 60
- title
- Any TEAE
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 31
- title
- Any TEAE Grade 3 or 4
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 44
- title
- Any Treatment-Related TEAE
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 9
- title
- Any Treatment-Related TEAE Grade 3 or 4
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- title
- Any TEAE Leading to Dose Reduction or 4or() {
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 22
- title
- Any TEAE Leading to Study Drug Interruption��
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- title
- Any TEAE Leading to Study Drug Discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 23
- title
- Any TESAENR
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- title
- Any Treatment-Related TESAE
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Any Protocol Defined AE of Special Interestion
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 61
- units
- Participants
- groups
- description
- Subjects with relapsed orrefractory malignantmesothelioma regardless ofBAP1 status were to be treatedand PK blood samplescollected after a singletazemetostat 800 mg dose onCycle 1 Day 1 and afterrepeated twice daily doses oftazemetostat 800 mg on Cycle1 Day 15. Subjects were toreceive a single oral 800 mgtazemetostat dose on Cycle 1Day 1. Starting on Cycle 1 Day2, tazemetostat was orallyadministered at a dose of 800mg twice daily.
- id
- OG000
- title
- Part 1
- description
- Subjects with BAP1-deficientrelapsed or refractorymalignant mesothelioma wereto receive orally administeredtazemetostat 800 mg twicedaily starting on Cycle 1 Day1
- id
- OG001
- title
- Part 2
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- From the first dose of study treatment until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy.
- title
- Incidence of Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
- type
- PRIMARY
- unit Of Measure
- Participants
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