TriangleNCT02639546 · OUTCOME
Percentage of Participants With Adverse Events (AEs), Including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
What was measured
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs.
Analysis population: The safety evaluable population was defined as all participants who received at least one dose of study drug.
Groups in this outcome
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
Phase I (Tablet) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
Phase I (Suspension) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
Phase II (Suspension) Cobimetinib (1 mg/kg)
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
| Group | Source count |
|---|---|
| Phase I (Tablet) Cobimetinib (0.6 mg/kg) | 6 |
| Phase I (Tablet) Cobimetinib (0.8 mg/kg) | 6 |
| Phase I (Tablet) Cobimetinib (1 mg/kg) | 6 |
| Phase I (Suspension) Cobimetinib (0.6 mg/kg) | 6 |
| Phase I (Suspension) Cobimetinib (0.8 mg/kg) | 7 |
| Phase I (Suspension) Cobimetinib (1 mg/kg) | 8 |
| Phase I (Suspension) Cobimetinib (1.33 mg/kg) | 5 |
| Phase II (Suspension) Cobimetinib (1 mg/kg) | 12 |
Reported measurements
AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I (Tablet) Cobimetinib (0.6 mg/kg) | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Phase I (Tablet) Cobimetinib (0.8 mg/kg) | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Phase I (Tablet) Cobimetinib (1 mg/kg) | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (0.6 mg/kg) | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (0.8 mg/kg) | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (1 mg/kg) | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (1.33 mg/kg) | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Phase II (Suspension) Cobimetinib (1 mg/kg) | 100.0 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I (Tablet) Cobimetinib (0.6 mg/kg) | 33.3 | Not reported | Not reported | Not reported | Not reported |
| Phase I (Tablet) Cobimetinib (0.8 mg/kg) | 33.3 | Not reported | Not reported | Not reported | Not reported |
| Phase I (Tablet) Cobimetinib (1 mg/kg) | 33.3 | Not reported | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (0.6 mg/kg) | 33.3 | Not reported | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (0.8 mg/kg) | 14.3 | Not reported | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (1 mg/kg) | 25.0 | Not reported | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (1.33 mg/kg) | 40.0 | Not reported | Not reported | Not reported | Not reported |
| Phase II (Suspension) Cobimetinib (1 mg/kg) | 41.7 | Not reported | Not reported | Not reported | Not reported |
AESIs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I (Tablet) Cobimetinib (0.6 mg/kg) | 33.3 | Not reported | Not reported | Not reported | Not reported |
| Phase I (Tablet) Cobimetinib (0.8 mg/kg) | 33.3 | Not reported | Not reported | Not reported | Not reported |
| Phase I (Tablet) Cobimetinib (1 mg/kg) | 33.3 | Not reported | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (0.6 mg/kg) | 50.0 | Not reported | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (0.8 mg/kg) | 42.9 | Not reported | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (1 mg/kg) | 25.0 | Not reported | Not reported | Not reported | Not reported |
| Phase I (Suspension) Cobimetinib (1.33 mg/kg) | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Phase II (Suspension) Cobimetinib (1 mg/kg) | 58.3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 100.0
- group Id
- OG001
- value
- 100.0
- group Id
- OG002
- value
- 100.0
- group Id
- OG003
- value
- 100.0
- group Id
- OG004
- value
- 100.0
- group Id
- OG005
- value
- 100.0
- group Id
- OG006
- value
- 100.0
- group Id
- OG007
- value
- 100.0
- title
- AEs
- categories
- measurements
- group Id
- OG000
- value
- 33.3
- group Id
- OG001
- value
- 33.3
- group Id
- OG002
- value
- 33.3
- group Id
- OG003
- value
- 33.3
- group Id
- OG004
- value
- 14.3
- group Id
- OG005
- value
- 25.0
- group Id
- OG006
- value
- 40.0
- group Id
- OG007
- value
- 41.7
- title
- SAEs
- categories
- measurements
- group Id
- OG000
- value
- 33.3
- group Id
- OG001
- value
- 33.3
- group Id
- OG002
- value
- 33.3
- group Id
- OG003
- value
- 50.0
- group Id
- OG004
- value
- 42.9
- group Id
- OG005
- value
- 25.0
- group Id
- OG006
- value
- 100.0
- group Id
- OG007
- value
- 58.3
- title
- AESIs
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 12
- units
- Participants
- description
- An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs.
- groups
- description
- Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
- id
- OG000
- title
- Phase I (Tablet) Cobimetinib (0.6 mg/kg)
- description
- Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
- id
- OG001
- title
- Phase I (Tablet) Cobimetinib (0.8 mg/kg)
- description
- Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
- id
- OG002
- title
- Phase I (Tablet) Cobimetinib (1 mg/kg)
- description
- Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
- id
- OG003
- title
- Phase I (Suspension) Cobimetinib (0.6 mg/kg)
- description
- Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
- id
- OG004
- title
- Phase I (Suspension) Cobimetinib (0.8 mg/kg)
- description
- Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
- id
- OG005
- title
- Phase I (Suspension) Cobimetinib (1 mg/kg)
- description
- Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
- id
- OG006
- title
- Phase I (Suspension) Cobimetinib (1.33 mg/kg)
- description
- Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
- id
- OG007
- title
- Phase II (Suspension) Cobimetinib (1 mg/kg)
- param Type
- NUMBER
- population Description
- The safety evaluable population was defined as all participants who received at least one dose of study drug.
- reporting Status
- POSTED
- time Frame
- Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
- title
- Percentage of Participants With Adverse Events (AEs), Including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
- type
- PRIMARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice