TriangleNCT03797326 · OUTCOME
Number of Participants Who Discontinued From Study Treatment Due to an 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 approximately 62 months
What was measured
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, 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 study intervention. The number of participants who discontinued from study treatment due to an AE is presented.
Analysis population: All allocated participants who received at least 1 dose of study intervention.
Groups in this outcome
Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)
Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Cohort B: Ovarian Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Cohort C: Gastric Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Cohort D1: Colorectal Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Cohort D2: Colorectal Cancer (Lenva)
Participants received Lenva 24 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Cohort E: Glioblastoma Multiforma (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Cohort F: Biliary Tract Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Cohort G: Pancreatic Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
| Group | Source count |
|---|---|
| Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) | 31 |
| Cohort B: Ovarian Cancer (Lenva + Pembro) | 31 |
| Cohort C: Gastric Cancer (Lenva + Pembro) | 99 |
| Cohort D1: Colorectal Cancer (Lenva + Pembro) | 105 |
| Cohort D2: Colorectal Cancer (Lenva) | 30 |
| Cohort E: Glioblastoma Multiforma (Lenva + Pembro) | 101 |
| Cohort F: Biliary Tract Cancer (Lenva + Pembro) | 102 |
| Cohort G: Pancreatic Cancer (Lenva + Pembro) | 103 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort B: Ovarian Cancer (Lenva + Pembro) | 11 | Not reported | Not reported | Not reported | Not reported |
| Cohort C: Gastric Cancer (Lenva + Pembro) | 23 | Not reported | Not reported | Not reported | Not reported |
| Cohort D1: Colorectal Cancer (Lenva + Pembro) | 19 | Not reported | Not reported | Not reported | Not reported |
| Cohort D2: Colorectal Cancer (Lenva) | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort E: Glioblastoma Multiforma (Lenva + Pembro) | 11 | Not reported | Not reported | Not reported | Not reported |
| Cohort F: Biliary Tract Cancer (Lenva + Pembro) | 20 | Not reported | Not reported | Not reported | Not reported |
| Cohort G: Pancreatic Cancer (Lenva + Pembro) | 19 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 23
- group Id
- OG003
- value
- 19
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 11
- group Id
- OG006
- value
- 20
- group Id
- OG007
- value
- 19
- denoms
- counts
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 31
- group Id
- OG002
- value
- 99
- group Id
- OG003
- value
- 105
- group Id
- OG004
- value
- 30
- group Id
- OG005
- value
- 101
- group Id
- OG006
- value
- 102
- group Id
- OG007
- value
- 103
- units
- Participants
- description
- An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, 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 study intervention. The number of participants who discontinued from study treatment due to an AE is presented.
- groups
- description
- Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
- id
- OG000
- title
- Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)
- description
- Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
- id
- OG001
- title
- Cohort B: Ovarian Cancer (Lenva + Pembro)
- description
- Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
- id
- OG002
- title
- Cohort C: Gastric Cancer (Lenva + Pembro)
- description
- Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
- id
- OG003
- title
- Cohort D1: Colorectal Cancer (Lenva + Pembro)
- description
- Participants received Lenva 24 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
- id
- OG004
- title
- Cohort D2: Colorectal Cancer (Lenva)
- description
- Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
- id
- OG005
- title
- Cohort E: Glioblastoma Multiforma (Lenva + Pembro)
- description
- Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
- id
- OG006
- title
- Cohort F: Biliary Tract Cancer (Lenva + Pembro)
- description
- Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
- id
- OG007
- title
- Cohort G: Pancreatic Cancer (Lenva + Pembro)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All allocated participants who received at least 1 dose of study intervention.
- reporting Status
- POSTED
- time Frame
- Up to approximately 62 months
- title
- Number of Participants Who Discontinued From Study Treatment Due to an AE
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice