NCT01682083 · OUTCOME
All Collected Deaths
Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD). · Source last updated 2026-04-21
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
- Pre-treatment deaths: Up to 28 days prior to treatment. On-treatment deaths: Up to approximately 12 months. Post-treatment deaths: Up to approximately 126 months
What was measured
Pre-treatment deaths were collected from day of participant's informed consent to the day before first dose of study medication.
On-treatment deaths were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approximately 12 months.
Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approximately 126 months.
Analysis population: Intent-to-Treat (ITT) Population
Groups in this outcome
Dabrafenib and Trametinib Combination Therapy
Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
Dabrafenib and Trametinib Placebos
Subjects received matching placebos orally for 12 months
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 |
|---|
| Dabrafenib and Trametinib Combination Therapy | 438 |
|---|
| Dabrafenib and Trametinib Placebos | 432 |
|---|
Reported measurements
Pre-treatment deaths
Analysis denominator · Participants
| Group | Source count |
|---|
| Dabrafenib and Trametinib Combination Therapy | 438 |
|---|
| Dabrafenib and Trametinib Placebos | 432 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dabrafenib and Trametinib Combination Therapy | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dabrafenib and Trametinib Placebos | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
On-treatment deaths
Analysis denominator · Participants
| Group | Source count |
|---|
| Dabrafenib and Trametinib Combination Therapy | 435 |
|---|
| Dabrafenib and Trametinib Placebos | 432 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dabrafenib and Trametinib Combination Therapy | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dabrafenib and Trametinib Placebos | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Post-treatment deaths
Analysis denominator · Participants
| Group | Source count |
|---|
| Dabrafenib and Trametinib Combination Therapy | 431 |
|---|
| Dabrafenib and Trametinib Placebos | 431 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dabrafenib and Trametinib Combination Therapy | 121 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dabrafenib and Trametinib Placebos | 135 | Not reported | Not reported | Not reported | Not reported |
|---|
All deaths
Analysis denominator · Participants
| Group | Source count |
|---|
| Dabrafenib and Trametinib Combination Therapy | 438 |
|---|
| Dabrafenib and Trametinib Placebos | 432 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dabrafenib and Trametinib Combination Therapy | 125 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dabrafenib and Trametinib Placebos | 136 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 438
- group Id
- OG001
- value
- 432
- units
- Participants
- title
- Pre-treatment deaths
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 435
- group Id
- OG001
- value
- 432
- units
- Participants
- title
- On-treatment deaths
- categories
- measurements
- group Id
- OG000
- value
- 121
- group Id
- OG001
- value
- 135
- denoms
- counts
- group Id
- OG000
- value
- 431
- group Id
- OG001
- value
- 431
- units
- Participants
- title
- Post-treatment deaths
- categories
- measurements
- group Id
- OG000
- value
- 125
- group Id
- OG001
- value
- 136
- denoms
- counts
- group Id
- OG000
- value
- 438
- group Id
- OG001
- value
- 432
- units
- Participants
- title
- All deaths
- denoms
- counts
- group Id
- OG000
- value
- 438
- group Id
- OG001
- value
- 432
- units
- Participants
- description
- Pre-treatment deaths were collected from day of participant's informed consent to the day before first dose of study medication.
On-treatment deaths were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approximately 12 months.
Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approximately 126 months.
- groups
- description
- Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
- id
- OG000
- title
- Dabrafenib and Trametinib Combination Therapy
- description
- Subjects received matching placebos orally for 12 months
- id
- OG001
- title
- Dabrafenib and Trametinib Placebos
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Intent-to-Treat (ITT) Population
- reporting Status
- POSTED
- time Frame
- Pre-treatment deaths: Up to 28 days prior to treatment. On-treatment deaths: Up to approximately 12 months. Post-treatment deaths: Up to approximately 126 months
- 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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