TriangleNCT03989115 · 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
- AEs were collected from the start of intervention through 30 days post last day of study drug taken. Participants were monitored/assessed for adverse events for a maximum of 17 months which includes a maximum duration of 16 months on treatment.
What was measured
An adverse event (AE) was defined as any untoward medical occurrence in a participant, temporally associated with the use of a pharmaceutical / an investigational product, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product(s) was also an AE. All AEs and SAEs will be collected from the start of intervention until the safety visit or EOT visit, whichever is later. The number of safety-evaluable participants who experienced at least one treatment-emergent AE was reported per protocol.
Analysis population: All safety-evaluable participants who experienced at least one treatment-emergent AE.
Groups in this outcome
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 20mg QD (21/7)
Participants who received intermittent dose of RMC-4630 80 mg on D1 and D4 of a 28-day cycle and Cobimetinib 20 mg QD 21days on and 7 days off of a 28-day cycle.
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 40mg QD (21/7)
Participants who received intermittent dose of RMC-4630 80mg on D1 and D4 of a 28-day cycle and Cobimetinib 40mg QD 21days on and 7 days off of a 28-day cycle.
Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7)
Participants who received intermittent dose of RMC-4630 140 mg on D1 and D4 of a 28-day cycle and Cobimetinib 20mg QD 21days on and 7 days off of a 28-day cycle.
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7)
Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 20mg QD 21days on and 7 days off of a 28-day cycle.
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)
Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 40mg D1 and D2 of a 28-day cycle.
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D2
Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 60mg D1 and D2 of a 28-day cycle.
Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD)
Participants who received intermittent dose of RMC-4630 100 mg on D1 and D2 of a 28-day cycle and daily dose of Osimertinib 80 mg from D1 through D28 of a 28-day cycle.
Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)
Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and daily dose of Osimertinib 80 mg from D1 through D28 of a 28-day cycle.
| Group | Source count |
|---|---|
| Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 20mg QD (21/7) | 8 |
| Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 40mg QD (21/7) | 6 |
| Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7) | 12 |
| Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7) | 7 |
| Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2) | 65 |
| Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D2 | 7 |
| Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD) | 4 |
| Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD) | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 20mg QD (21/7) | 8 | Not reported | Not reported | Not reported | Not reported |
| Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 40mg QD (21/7) | 6 | Not reported | Not reported | Not reported | Not reported |
| Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7) | 12 | Not reported | Not reported | Not reported | Not reported |
| Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7) | 7 | Not reported | Not reported | Not reported | Not reported |
| Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2) | 64 | Not reported | Not reported | Not reported | Not reported |
| Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D2 | 7 | Not reported | Not reported | Not reported | Not reported |
| Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD) | 4 | Not reported | Not reported | Not reported | Not reported |
| Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD) | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 64
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 65
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 4
- units
- Participants
- description
- An adverse event (AE) was defined as any untoward medical occurrence in a participant, temporally associated with the use of a pharmaceutical / an investigational product, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product(s) was also an AE. All AEs and SAEs will be collected from the start of intervention until the safety visit or EOT visit, whichever is later. The number of safety-evaluable participants who experienced at least one treatment-emergent AE was reported per protocol.
- groups
- description
- Participants who received intermittent dose of RMC-4630 80 mg on D1 and D4 of a 28-day cycle and Cobimetinib 20 mg QD 21days on and 7 days off of a 28-day cycle.
- id
- OG000
- title
- Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 20mg QD (21/7)
- description
- Participants who received intermittent dose of RMC-4630 80mg on D1 and D4 of a 28-day cycle and Cobimetinib 40mg QD 21days on and 7 days off of a 28-day cycle.
- id
- OG001
- title
- Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 40mg QD (21/7)
- description
- Participants who received intermittent dose of RMC-4630 140 mg on D1 and D4 of a 28-day cycle and Cobimetinib 20mg QD 21days on and 7 days off of a 28-day cycle.
- id
- OG002
- title
- Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7)
- description
- Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 20mg QD 21days on and 7 days off of a 28-day cycle.
- id
- OG003
- title
- Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7)
- description
- Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 40mg D1 and D2 of a 28-day cycle.
- id
- OG004
- title
- Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)
- description
- Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 60mg D1 and D2 of a 28-day cycle.
- id
- OG005
- title
- Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D2
- description
- Participants who received intermittent dose of RMC-4630 100 mg on D1 and D2 of a 28-day cycle and daily dose of Osimertinib 80 mg from D1 through D28 of a 28-day cycle.
- id
- OG006
- title
- Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD)
- description
- Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and daily dose of Osimertinib 80 mg from D1 through D28 of a 28-day cycle.
- id
- OG007
- title
- Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All safety-evaluable participants who experienced at least one treatment-emergent AE.
- reporting Status
- POSTED
- time Frame
- AEs were collected from the start of intervention through 30 days post last day of study drug taken. Participants were monitored/assessed for adverse events for a maximum of 17 months which includes a maximum duration of 16 months on treatment.
- title
- Number of Participants With Adverse Events (AEs).
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice