TriangleNCT02034110 · OUTCOME
Number of Participants With Adverse Events (AEs)
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 study treatment start date till 30 days safety follow-up, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
What was measured
The distribution of adverse events (AE) was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs) and Serious Adverse Event (TESAEs) through the monitoring of relevant clinical and laboratory safety parameters.
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
Any AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Anaplastic Thyroid Cancer (ATC) | 36 | Not reported | Not reported | Not reported | Not reported |
| Biliary Tract Cancer (BTC) | 43 | 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) | 12 | Not reported | Not reported | Not reported | Not reported |
| High Grade (WHO G3/G4) Glioma (HGG) | 42 | 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) | 55 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM) | 9 | Not reported | Not reported | Not reported | Not reported |
AEs related to study treatment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Anaplastic Thyroid Cancer (ATC) | 27 | Not reported | Not reported | Not reported | Not reported |
| Biliary Tract Cancer (BTC) | 42 | 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) | 12 | Not reported | Not reported | Not reported | Not reported |
| High Grade (WHO G3/G4) Glioma (HGG) | 37 | 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) | 52 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM) | 7 | Not reported | Not reported | Not reported | Not reported |
AEs leading to permanent discontinuation of any study treatment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Anaplastic Thyroid Cancer (ATC) | 6 | Not reported | Not reported | Not reported | Not reported |
| Biliary Tract Cancer (BTC) | 1 | 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) | 2 | Not reported | Not reported | Not reported | Not reported |
| High Grade (WHO G3/G4) Glioma (HGG) | 4 | Not reported | Not reported | Not reported | Not reported |
| Adenocarcinoma of the Small Intestine (ASI) | 1 | Not reported | Not reported | Not reported | Not reported |
| Hairy Cell Leukemia (HCL) | 13 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM) | 1 | Not reported | Not reported | Not reported | Not reported |
AEs leading to dose reduction
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Anaplastic Thyroid Cancer (ATC) | 17 | Not reported | Not reported | Not reported | Not reported |
| Biliary Tract Cancer (BTC) | 15 | 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) | 18 | Not reported | Not reported | Not reported | Not reported |
| Adenocarcinoma of the Small Intestine (ASI) | 2 | Not reported | Not reported | Not reported | Not reported |
| Hairy Cell Leukemia (HCL) | 29 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM) | 5 | Not reported | Not reported | Not reported | Not reported |
AEs leading to dose interruption/delay
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Anaplastic Thyroid Cancer (ATC) | 19 | Not reported | Not reported | Not reported | Not reported |
| Biliary Tract Cancer (BTC) | 24 | 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) | 6 | Not reported | Not reported | Not reported | Not reported |
| High Grade (WHO G3/G4) Glioma (HGG) | 18 | Not reported | Not reported | Not reported | Not reported |
| Adenocarcinoma of the Small Intestine (ASI) | 2 | Not reported | Not reported | Not reported | Not reported |
| Hairy Cell Leukemia (HCL) | 40 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM) | 6 | Not reported | Not reported | Not reported | Not reported |
Any SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Anaplastic Thyroid Cancer (ATC) | 20 | Not reported | Not reported | Not reported | Not reported |
| Biliary Tract Cancer (BTC) | 17 | 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) | 16 | 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) | 32 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM) | 4 | Not reported | Not reported | Not reported | Not reported |
SAEs related to study treatment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Anaplastic Thyroid Cancer (ATC) | 7 | Not reported | Not reported | Not reported | Not reported |
| Biliary Tract Cancer (BTC) | 9 | 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) | 7 | 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) | 19 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM) | 3 | Not reported | Not reported | Not reported | Not reported |
Fatal SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Anaplastic Thyroid Cancer (ATC) | 3 | Not reported | Not reported | Not reported | Not reported |
| Biliary Tract Cancer (BTC) | 2 | 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) | 0 | Not reported | Not reported | Not reported | Not reported |
| High Grade (WHO G3/G4) Glioma (HGG) | 1 | 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) | 3 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 43
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 42
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 55
- group Id
- OG007
- value
- 9
- title
- Any AE
- categories
- measurements
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 42
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 37
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 52
- group Id
- OG007
- value
- 7
- title
- AEs related to study treatment
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 13
- group Id
- OG007
- value
- 1
- title
- AEs leading to permanent discontinuation of any study treatment
- categories
- measurements
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 18
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 29
- group Id
- OG007
- value
- 5
- title
- AEs leading to dose reduction
- categories
- measurements
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 18
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 40
- group Id
- OG007
- value
- 6
- title
- AEs leading to dose interruption/delay
- categories
- measurements
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 17
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 16
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 32
- group Id
- OG007
- value
- 4
- title
- Any SAE
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 19
- group Id
- OG007
- value
- 3
- title
- SAEs related to study treatment
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 0
- title
- Fatal SAEs
- 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
- The distribution of adverse events (AE) was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs) and Serious Adverse Event (TESAEs) through the monitoring of relevant clinical and laboratory safety parameters.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- All-treated Subjects (ATS) population - Primary and expansion cohort combined
- reporting Status
- POSTED
- time Frame
- From study treatment start date till 30 days safety follow-up, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
- title
- Number of Participants With Adverse Events (AEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice