TriangleNCT01584648 · OUTCOME
Number of Participants With Adverse Events and Serious Adverse Events
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 time the first dose of study treatment administered until 30 days after discontinuation of study treatment (up to approximately 6 years).
What was measured
Analysis of absolute and relative frequencies for Adverse Event (AE) and Serious Adverse Event (SAE) by primary System Organ Class (SOC) to characterize the safety of dabrafenib and trametinib combination therapy through the monitoring of relevant clinical and laboratory safety parameters. In addition, new malignancies and AEs possibly related to study treatment were collected even if they occurred more than 30 days post-treatment. Only descriptive analysis performed.
Analysis population: Safety Population: all randomized participants who received at least one dose of study medication and were based on the actual treatment received if this differed from that to which the participant was randomized.
Groups in this outcome
Dabrafenib + Trametinib
Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
Dabrafenib + Placebo
Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Crossover to the combination therapy arm was allowed for subjects still receiving study treatment on the dabrafenib monotherapy arm after the positive result for the final OS analysis.
Crossover Dabrafenib + Trametinib
Crossover Dabrafenib + Trametinib
| Group | Source count |
|---|---|
| Dabrafenib + Trametinib | 209 |
| Dabrafenib + Placebo | 211 |
| Crossover Dabrafenib + Trametinib | 28 |
Reported measurements
Adverse Event (AEs)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dabrafenib + Trametinib | 203 | Not reported | Not reported | Not reported | Not reported |
| Dabrafenib + Placebo | 205 | Not reported | Not reported | Not reported | Not reported |
| Crossover Dabrafenib + Trametinib | 24 | Not reported | Not reported | Not reported | Not reported |
Serious Adverse Event (SAEs)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dabrafenib + Trametinib | 100 | Not reported | Not reported | Not reported | Not reported |
| Dabrafenib + Placebo | 80 | Not reported | Not reported | Not reported | Not reported |
| Crossover Dabrafenib + Trametinib | 8 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 203
- group Id
- OG001
- value
- 205
- group Id
- OG002
- value
- 24
- title
- Adverse Event (AEs)
- categories
- measurements
- group Id
- OG000
- value
- 100
- group Id
- OG001
- value
- 80
- group Id
- OG002
- value
- 8
- title
- Serious Adverse Event (SAEs)
- denoms
- counts
- group Id
- OG000
- value
- 209
- group Id
- OG001
- value
- 211
- group Id
- OG002
- value
- 28
- units
- Participants
- description
- Analysis of absolute and relative frequencies for Adverse Event (AE) and Serious Adverse Event (SAE) by primary System Organ Class (SOC) to characterize the safety of dabrafenib and trametinib combination therapy through the monitoring of relevant clinical and laboratory safety parameters. In addition, new malignancies and AEs possibly related to study treatment were collected even if they occurred more than 30 days post-treatment. Only descriptive analysis performed.
- groups
- description
- Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
- id
- OG000
- title
- Dabrafenib + Trametinib
- description
- Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Crossover to the combination therapy arm was allowed for subjects still receiving study treatment on the dabrafenib monotherapy arm after the positive result for the final OS analysis.
- id
- OG001
- title
- Dabrafenib + Placebo
- description
- Crossover Dabrafenib + Trametinib
- id
- OG002
- title
- Crossover Dabrafenib + Trametinib
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Population: all randomized participants who received at least one dose of study medication and were based on the actual treatment received if this differed from that to which the participant was randomized.
- reporting Status
- POSTED
- time Frame
- From the time the first dose of study treatment administered until 30 days after discontinuation of study treatment (up to approximately 6 years).
- title
- Number of Participants With Adverse Events and Serious Adverse Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice