TriangleNCT01713582 · OUTCOME
Number of Participants Who Experienced at Least One Adverse Event (AE)
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
- Up to 40 days after last dose of study therapy (Up to 28 months)
What was measured
AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. AEs were collected during the entire time frame of treatment plus up to 40 days of follow-up.
Analysis population: All participants who received at least one dose of study therapy.
Groups in this outcome
AL 10 mg QD 14-21
Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
AL 20 mg QD 14-21
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
AL 40 mg QD 14-21
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
AL 20 mg BID 21-21
Participants received 20 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
AL 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
AL 40 mg BID 14-21
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
AL 120 mg QD 14-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
AL 120 mg QD 21-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
AL 160 mg QD 14-21
Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
AML de Novo 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
AML/MDS 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
OHM 10 mg QD 21-21
Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
OHM 20 mg QD 21-21
Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
OHM 40 mg QD 21-21
Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
OHM 80 mg QD 21-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
OHM 40 mg BID 21-21
Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
OHM 120 mg QD 21-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
OHM 120 mg QD 14-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
OHM 120 mg QD 5-7
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.
OHM 120 mg QD 7-21
Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.
OHM/DLBCL 80 mg QD 14-21
Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
| Group | Source count |
|---|---|
| AL 10 mg QD 14-21 | 3 |
| AL 20 mg QD 14-21 | 3 |
| AL 40 mg QD 14-21 | 4 |
| AL 20 mg BID 21-21 | 3 |
| AL 80 mg QD 14-21 | 4 |
| AL 40 mg BID 14-21 | 8 |
| AL 120 mg QD 14-21 | 7 |
| AL 120 mg QD 21-21 | 6 |
| AL 160 mg QD 14-21 | 6 |
| AML de Novo 80 mg QD 14-21 | 18 |
| AML/MDS 80 mg QD 14-21 | 16 |
| OHM 10 mg QD 21-21 | 5 |
| OHM 20 mg QD 21-21 | 3 |
| OHM 40 mg QD 21-21 | 4 |
| OHM 80 mg QD 21-21 | 7 |
| OHM 40 mg BID 21-21 | 6 |
| OHM 120 mg QD 21-21 | 7 |
| OHM 120 mg QD 14-21 | 3 |
| OHM 120 mg QD 5-7 | 5 |
| OHM 120 mg QD 7-21 | 5 |
| OHM/DLBCL 80 mg QD 14-21 | 15 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AL 10 mg QD 14-21 | 3 | Not reported | Not reported | Not reported | Not reported |
| AL 20 mg QD 14-21 | 3 | Not reported | Not reported | Not reported | Not reported |
| AL 40 mg QD 14-21 | 4 | Not reported | Not reported | Not reported | Not reported |
| AL 20 mg BID 21-21 | 3 | Not reported | Not reported | Not reported | Not reported |
| AL 80 mg QD 14-21 | 4 | Not reported | Not reported | Not reported | Not reported |
| AL 40 mg BID 14-21 | 8 | Not reported | Not reported | Not reported | Not reported |
| AL 120 mg QD 14-21 | 7 | Not reported | Not reported | Not reported | Not reported |
| AL 120 mg QD 21-21 | 6 | Not reported | Not reported | Not reported | Not reported |
| AL 160 mg QD 14-21 | 6 | Not reported | Not reported | Not reported | Not reported |
| AML de Novo 80 mg QD 14-21 | 18 | Not reported | Not reported | Not reported | Not reported |
| AML/MDS 80 mg QD 14-21 | 16 | Not reported | Not reported | Not reported | Not reported |
| OHM 10 mg QD 21-21 | 5 | Not reported | Not reported | Not reported | Not reported |
| OHM 20 mg QD 21-21 | 3 | Not reported | Not reported | Not reported | Not reported |
| OHM 40 mg QD 21-21 | 4 | Not reported | Not reported | Not reported | Not reported |
| OHM 80 mg QD 21-21 | 7 | Not reported | Not reported | Not reported | Not reported |
| OHM 40 mg BID 21-21 | 6 | Not reported | Not reported | Not reported | Not reported |
| OHM 120 mg QD 21-21 | 7 | Not reported | Not reported | Not reported | Not reported |
| OHM 120 mg QD 14-21 | 3 | Not reported | Not reported | Not reported | Not reported |
| OHM 120 mg QD 5-7 | 5 | Not reported | Not reported | Not reported | Not reported |
| OHM 120 mg QD 7-21 | 5 | Not reported | Not reported | Not reported | Not reported |
| OHM/DLBCL 80 mg QD 14-21 | 15 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 7
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 18
- group Id
- OG010
- value
- 16
- group Id
- OG011
- value
- 5
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 7
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 18
- group Id
- OG010
- value
- 16
- group Id
- OG011
- value
- 5
- units
- Participants
- description
- AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. AEs were collected during the entire time frame of treatment plus up to 40 days of follow-up.
- groups
- description
- Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
- id
- OG000
- title
- AL 10 mg QD 14-21
- description
- Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
- id
- OG001
- title
- AL 20 mg QD 14-21
- description
- Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
- id
- OG002
- title
- AL 40 mg QD 14-21
- description
- Participants received 20 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
- id
- OG003
- title
- AL 20 mg BID 21-21
- description
- Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
- id
- OG004
- title
- AL 80 mg QD 14-21
- description
- Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
- id
- OG005
- title
- AL 40 mg BID 14-21
- description
- Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
- id
- OG006
- title
- AL 120 mg QD 14-21
- description
- Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
- id
- OG007
- title
- AL 120 mg QD 21-21
- description
- Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
- id
- OG008
- title
- AL 160 mg QD 14-21
- description
- Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
- id
- OG009
- title
- AML de Novo 80 mg QD 14-21
- description
- Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
- id
- OG010
- title
- AML/MDS 80 mg QD 14-21
- description
- Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
- id
- OG011
- title
- OHM 10 mg QD 21-21
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants who received at least one dose of study therapy.
- reporting Status
- POSTED
- time Frame
- Up to 40 days after last dose of study therapy (Up to 28 months)
- title
- Number of Participants Who Experienced at Least One Adverse Event (AE)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice