NCT02034110 · 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 deaths: Up to 85 months. Post-treatment survival follow-up deaths: Up to 92 months.
What was measured
On-treatment deaths were collected from first dose of study medication to 30 days after study drug discontinuation, for a maximum duration of 85 months. Post-treatment survival follow-up deaths were collected from day 31 after last dose of first dose of study medication, up to 92 months. All deaths refer to the sum of on-treatment deaths and post-treatment survival follow-up deaths.
Analysis population: All-treated Subjects (ATS) population - Primary and expansion cohort combined
Groups in this outcome
Anaplastic Thyroid Cancer (ATC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
| Group | Source count |
|---|---|
| Anaplastic Thyroid Cancer (ATC) | 36 |
| Biliary Tract Cancer (BTC) | 43 |
| Gastrointestinal Stromal Tumor (GIST) | 1 |
| Low Grade (WHO G1/G2) Glioma (LGG) | 13 |
| High Grade (WHO G3/G4) Glioma (HGG) | 45 |
| Adenocarcinoma of the Small Intestine (ASI) | 3 |
| Hairy Cell Leukemia (HCL) | 55 |
| Multiple Myeloma (MM) | 10 |
Reported measurements
On-treatment deaths
| Group | Source count |
|---|---|
| Anaplastic Thyroid Cancer (ATC) | 36 |
| Biliary Tract Cancer (BTC) | 43 |
| Gastrointestinal Stromal Tumor (GIST) | 1 |
| Low Grade (WHO G1/G2) Glioma (LGG) | 13 |
| High Grade (WHO G3/G4) Glioma (HGG) | 45 |
| Adenocarcinoma of the Small Intestine (ASI) | 3 |
| Hairy Cell Leukemia (HCL) | 55 |
| Multiple Myeloma (MM) | 10 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Anaplastic Thyroid Cancer (ATC) | 6 | Not reported | Not reported | Not reported | Not reported |
| Biliary Tract Cancer (BTC) | 6 | Not reported | Not reported | Not reported | Not reported |
| Gastrointestinal Stromal Tumor (GIST) | 0 | Not reported | Not reported | Not reported | Not reported |
| Low Grade (WHO G1/G2) Glioma (LGG) | 1 | Not reported | Not reported | Not reported | Not reported |
| High Grade (WHO G3/G4) Glioma (HGG) | 2 | Not reported | Not reported | Not reported | Not reported |
| Adenocarcinoma of the Small Intestine (ASI) | 0 | Not reported | Not reported | Not reported | Not reported |
| Hairy Cell Leukemia (HCL) | 4 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM) | 1 | Not reported | Not reported | Not reported | Not reported |
Post-treatment survival follow-up deaths
| Group | Source count |
|---|---|
| Anaplastic Thyroid Cancer (ATC) | 30 |
| Biliary Tract Cancer (BTC) | 37 |
| Gastrointestinal Stromal Tumor (GIST) | 1 |
| Low Grade (WHO G1/G2) Glioma (LGG) | 12 |
| High Grade (WHO G3/G4) Glioma (HGG) | 43 |
| Adenocarcinoma of the Small Intestine (ASI) | 3 |
| Hairy Cell Leukemia (HCL) | 51 |
| Multiple Myeloma (MM) | 9 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Anaplastic Thyroid Cancer (ATC) | 18 | Not reported | Not reported | Not reported | Not reported |
| Biliary Tract Cancer (BTC) | 28 | Not reported | Not reported | Not reported | Not reported |
| Gastrointestinal Stromal Tumor (GIST) | 1 | Not reported | Not reported | Not reported | Not reported |
| Low Grade (WHO G1/G2) Glioma (LGG) | 3 | Not reported | Not reported | Not reported | Not reported |
| High Grade (WHO G3/G4) Glioma (HGG) | 26 | Not reported | Not reported | Not reported | Not reported |
| Adenocarcinoma of the Small Intestine (ASI) | 3 | Not reported | Not reported | Not reported | Not reported |
| Hairy Cell Leukemia (HCL) | 4 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM) | 8 | Not reported | Not reported | Not reported | Not reported |
All deaths
| Group | Source count |
|---|---|
| Anaplastic Thyroid Cancer (ATC) | 36 |
| Biliary Tract Cancer (BTC) | 43 |
| Gastrointestinal Stromal Tumor (GIST) | 1 |
| Low Grade (WHO G1/G2) Glioma (LGG) | 13 |
| High Grade (WHO G3/G4) Glioma (HGG) | 45 |
| Adenocarcinoma of the Small Intestine (ASI) | 3 |
| Hairy Cell Leukemia (HCL) | 55 |
| Multiple Myeloma (MM) | 10 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Anaplastic Thyroid Cancer (ATC) | 24 | Not reported | Not reported | Not reported | Not reported |
| Biliary Tract Cancer (BTC) | 34 | Not reported | Not reported | Not reported | Not reported |
| Gastrointestinal Stromal Tumor (GIST) | 1 | Not reported | Not reported | Not reported | Not reported |
| Low Grade (WHO G1/G2) Glioma (LGG) | 4 | Not reported | Not reported | Not reported | Not reported |
| High Grade (WHO G3/G4) Glioma (HGG) | 28 | Not reported | Not reported | Not reported | Not reported |
| Adenocarcinoma of the Small Intestine (ASI) | 3 | Not reported | Not reported | Not reported | Not reported |
| Hairy Cell Leukemia (HCL) | 8 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM) | 9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 43
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 45
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 55
- group Id
- OG007
- value
- 10
- units
- Participants
- title
- On-treatment deaths
- categories
- measurements
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 28
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 26
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 8
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 37
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 43
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 51
- group Id
- OG007
- value
- 9
- units
- Participants
- title
- Post-treatment survival follow-up deaths
- categories
- measurements
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 34
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 28
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 9
- denoms
- counts
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 43
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 45
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 55
- group Id
- OG007
- value
- 10
- units
- Participants
- title
- All deaths
- denoms
- counts
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 43
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 45
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 55
- group Id
- OG007
- value
- 10
- units
- Participants
- description
- On-treatment deaths were collected from first dose of study medication to 30 days after study drug discontinuation, for a maximum duration of 85 months. Post-treatment survival follow-up deaths were collected from day 31 after last dose of first dose of study medication, up to 92 months. All deaths refer to the sum of on-treatment deaths and post-treatment survival follow-up deaths.
- groups
- description
- All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
- id
- OG000
- title
- Anaplastic Thyroid Cancer (ATC)
- description
- All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
- id
- OG001
- title
- Biliary Tract Cancer (BTC)
- description
- All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
- id
- OG002
- title
- Gastrointestinal Stromal Tumor (GIST)
- description
- All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
- id
- OG003
- title
- Low Grade (WHO G1/G2) Glioma (LGG)
- description
- All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
- id
- OG004
- title
- High Grade (WHO G3/G4) Glioma (HGG)
- description
- All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
- id
- OG005
- title
- Adenocarcinoma of the Small Intestine (ASI)
- description
- All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
- id
- OG006
- title
- Hairy Cell Leukemia (HCL)
- description
- All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
- id
- OG007
- title
- Multiple Myeloma (MM)
- param Type
- NUMBER
- population Description
- All-treated Subjects (ATS) population - Primary and expansion cohort combined
- reporting Status
- POSTED
- time Frame
- On-treatment deaths: Up to 85 months. Post-treatment survival follow-up deaths: Up to 92 months.
- title
- All Collected Deaths
- type
- POST_HOC
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice
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