NCT02414139 · OUTCOME
All Collected Deaths
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- On-treatment: Up to approximately 5.5 years. Post-treatment efficacy/survival follow-up: Up to approximately 6 years
What was measured
On-treatment deaths were collected from start of treatment to 30 days after last dose of treatment. Post-treatment efficacy/survival follow-up deaths were collected from 31 days after last dose of treatment until the end of the study. All deaths refer to the sum of on-treatment and post-treatment efficacy/survival follow-up deaths.
Analysis population: FAS, including all subjects who received at least one dose of capmatinib
Groups in this outcome
Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)
Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L)
Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)
Pre-treated patients with MET GCN ≥ 6 and \< 10 treated with INC280 at 400 mg BID as second or third line (2/3L)
Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)
Pre-treated patients with MET GCN ≥ 4 and \< 6 treated with INC280 at 400mg BID as second or third line (2/3L)
Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)
Pre-treated patients with MET GCN \< 4 treated with INC280 at 400mg BID as second or third line (2/3L)
Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L)
Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)
Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L)
Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L)
Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)
Pre-treated patients with MET GCN ≥ 10 without MET mutation treated with INC280 at 400 mg BID as second line (2L) (expansion cohort of Cohort 1a)
Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as second line (2L)(expansion of Cohort 4)
Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) (expansion cohort of Cohort 5b)
Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
All pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L). (Participants from Cohort 4 and Cohort 6.2)
Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L)
All treatment naive patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as first line (1L) (Participants from Cohort 5b and Cohort 7)
All Participants
All participants
| Group | Source count |
|---|---|
| Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L) | 69 |
| Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L) | 42 |
| Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L) | 54 |
| Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L) | 30 |
| Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 69 |
| Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L) | 15 |
| Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L) | 28 |
| Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L) | 3 |
| Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L) | 31 |
| Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L) | 32 |
| Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 100 |
| Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L) | 60 |
| All Participants | 373 |
Reported measurements
On-treatment
| Group | Source count |
|---|---|
| Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L) | 69 |
| Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L) | 42 |
| Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L) | 54 |
| Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L) | 30 |
| Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 69 |
| Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L) | 15 |
| Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L) | 28 |
| Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L) | 3 |
| Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L) | 31 |
| Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L) | 32 |
| Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 100 |
| Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L) | 60 |
| All Participants | 373 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L) | 10 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L) | 7 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L) | 12 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L) | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 14 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L) | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L) | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L) | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L) | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L) | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 19 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L) | 10 | Not reported | Not reported | Not reported | Not reported |
| All Participants | 63 | Not reported | Not reported | Not reported | Not reported |
Post-treatment efficacy/survival follow-up
| Group | Source count |
|---|---|
| Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L) | 59 |
| Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L) | 35 |
| Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L) | 42 |
| Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L) | 25 |
| Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 55 |
| Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L) | 15 |
| Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L) | 20 |
| Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L) | 2 |
| Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L) | 20 |
| Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L) | 23 |
| Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 75 |
| Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L) | 43 |
| All Participants | 296 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L) | 44 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L) | 26 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L) | 34 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L) | 22 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 44 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L) | 13 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L) | 13 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L) | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L) | 17 | Not reported | Not reported | Not reported | Not reported |
| Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L) | 16 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 61 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L) | 29 | Not reported | Not reported | Not reported | Not reported |
| All Participants | 231 | Not reported | Not reported | Not reported | Not reported |
All deaths
| Group | Source count |
|---|---|
| Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L) | 69 |
| Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L) | 42 |
| Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L) | 54 |
| Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L) | 30 |
| Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 69 |
| Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L) | 15 |
| Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L) | 28 |
| Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L) | 3 |
| Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L) | 31 |
| Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L) | 32 |
| Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 100 |
| Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L) | 60 |
| All Participants | 373 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L) | 54 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L) | 33 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L) | 46 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L) | 26 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 58 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L) | 13 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L) | 18 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L) | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L) | 22 | Not reported | Not reported | Not reported | Not reported |
| Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L) | 21 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 80 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L) | 39 | Not reported | Not reported | Not reported | Not reported |
| All Participants | 294 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 14
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 5
- group Id
- OG010
- value
- 19
- group Id
- OG011
- value
- 10
- denoms
- counts
- group Id
- OG000
- value
- 69
- group Id
- OG001
- value
- 42
- group Id
- OG002
- value
- 54
- group Id
- OG003
- value
- 30
- group Id
- OG004
- value
- 69
- group Id
- OG005
- value
- 15
- group Id
- OG006
- value
- 28
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 31
- group Id
- OG009
- value
- 32
- group Id
- OG010
- value
- 100
- group Id
- OG011
- value
- 60
- units
- Participants
- title
- On-treatment
- categories
- measurements
- group Id
- OG000
- value
- 44
- group Id
- OG001
- value
- 26
- group Id
- OG002
- value
- 34
- group Id
- OG003
- value
- 22
- group Id
- OG004
- value
- 44
- group Id
- OG005
- value
- 13
- group Id
- OG006
- value
- 13
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 17
- group Id
- OG009
- value
- 16
- group Id
- OG010
- value
- 61
- group Id
- OG011
- value
- 29
- denoms
- counts
- group Id
- OG000
- value
- 59
- group Id
- OG001
- value
- 35
- group Id
- OG002
- value
- 42
- group Id
- OG003
- value
- 25
- group Id
- OG004
- value
- 55
- group Id
- OG005
- value
- 15
- group Id
- OG006
- value
- 20
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 20
- group Id
- OG009
- value
- 23
- group Id
- OG010
- value
- 75
- group Id
- OG011
- value
- 43
- units
- Participants
- title
- Post-treatment efficacy/survival follow-up
- categories
- measurements
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 33
- group Id
- OG002
- value
- 46
- group Id
- OG003
- value
- 26
- group Id
- OG004
- value
- 58
- group Id
- OG005
- value
- 13
- group Id
- OG006
- value
- 18
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 22
- group Id
- OG009
- value
- 21
- group Id
- OG010
- value
- 80
- group Id
- OG011
- value
- 39
- denoms
- counts
- group Id
- OG000
- value
- 69
- group Id
- OG001
- value
- 42
- group Id
- OG002
- value
- 54
- group Id
- OG003
- value
- 30
- group Id
- OG004
- value
- 69
- group Id
- OG005
- value
- 15
- group Id
- OG006
- value
- 28
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 31
- group Id
- OG009
- value
- 32
- group Id
- OG010
- value
- 100
- group Id
- OG011
- value
- 60
- units
- Participants
- title
- All deaths
- denoms
- counts
- group Id
- OG000
- value
- 69
- group Id
- OG001
- value
- 42
- group Id
- OG002
- value
- 54
- group Id
- OG003
- value
- 30
- group Id
- OG004
- value
- 69
- group Id
- OG005
- value
- 15
- group Id
- OG006
- value
- 28
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 31
- group Id
- OG009
- value
- 32
- group Id
- OG010
- value
- 100
- group Id
- OG011
- value
- 60
- units
- Participants
- description
- On-treatment deaths were collected from start of treatment to 30 days after last dose of treatment. Post-treatment efficacy/survival follow-up deaths were collected from 31 days after last dose of treatment until the end of the study. All deaths refer to the sum of on-treatment and post-treatment efficacy/survival follow-up deaths.
- groups
- description
- Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L)
- id
- OG000
- title
- Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)
- description
- Pre-treated patients with MET GCN ≥ 6 and \< 10 treated with INC280 at 400 mg BID as second or third line (2/3L)
- id
- OG001
- title
- Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)
- description
- Pre-treated patients with MET GCN ≥ 4 and \< 6 treated with INC280 at 400mg BID as second or third line (2/3L)
- id
- OG002
- title
- Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)
- description
- Pre-treated patients with MET GCN \< 4 treated with INC280 at 400mg BID as second or third line (2/3L)
- id
- OG003
- title
- Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)
- description
- Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L)
- id
- OG004
- title
- Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
- description
- Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L)
- id
- OG005
- title
- Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)
- description
- Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L)
- id
- OG006
- title
- Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)
- description
- Pre-treated patients with MET GCN ≥ 10 without MET mutation treated with INC280 at 400 mg BID as second line (2L) (expansion cohort of Cohort 1a)
- id
- OG007
- title
- Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)
- description
- Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as second line (2L)(expansion of Cohort 4)
- id
- OG008
- title
- Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)
- description
- Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) (expansion cohort of Cohort 5b)
- id
- OG009
- title
- Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)
- description
- All pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L). (Participants from Cohort 4 and Cohort 6.2)
- id
- OG010
- title
- Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
- description
- All treatment naive patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as first line (1L) (Participants from Cohort 5b and Cohort 7)
- id
- OG011
- title
- Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L)
- param Type
- NUMBER
- population Description
- FAS, including all subjects who received at least one dose of capmatinib
- reporting Status
- POSTED
- time Frame
- On-treatment: Up to approximately 5.5 years. Post-treatment efficacy/survival follow-up: Up to approximately 6 years
- title
- All Collected Deaths
- type
- POST_HOC
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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