TriangleNCT03615326 · OUTCOME
Number of Participants Who Discontinued Study Treatment Due to 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
- Up to 63 months
What was measured
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. 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 treatment. The number of participants who discontinued study treatment due to an AE is reported for each treatment arm. Per statistical analysis plan, data from the second course of pembrolizumab was not included in the safety analysis.
Analysis population: All randomized participants in the Global Cohort Pembrolizumab and SOC arms who received at least 1 dose of treatment, and all participants in the Japan-specific SOX Cohort who received at least 1 dose of treatment were included in this analysis. Per statistical analysis plan, data from the second course of pembrolizumab was not included in the safety analysis.
Groups in this outcome
Global Pembrolizumab + Standard of Care First Course
Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
Global Standard of Care First Course
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin
Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
Japan Trastuzumab + S-1 Plus Oxaliplatin
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
| Group | Source count |
|---|---|
| Global Pembrolizumab + Standard of Care First Course | 350 |
| Global Standard of Care First Course | 346 |
| Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin | 20 |
| Japan Trastuzumab + S-1 Plus Oxaliplatin | 20 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Global Pembrolizumab + Standard of Care First Course | 150 | Not reported | Not reported | Not reported | Not reported |
| Global Standard of Care First Course | 136 | Not reported | Not reported | Not reported | Not reported |
| Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin | 11 | Not reported | Not reported | Not reported | Not reported |
| Japan Trastuzumab + S-1 Plus Oxaliplatin | 11 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 150
- group Id
- OG001
- value
- 136
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 11
- denoms
- counts
- group Id
- OG000
- value
- 350
- group Id
- OG001
- value
- 346
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 20
- units
- Participants
- description
- An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. 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 treatment. The number of participants who discontinued study treatment due to an AE is reported for each treatment arm. Per statistical analysis plan, data from the second course of pembrolizumab was not included in the safety analysis.
- groups
- description
- Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
- id
- OG000
- title
- Global Pembrolizumab + Standard of Care First Course
- description
- Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
- id
- OG001
- title
- Global Standard of Care First Course
- description
- Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
- id
- OG002
- title
- Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin
- description
- Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
- id
- OG003
- title
- Japan Trastuzumab + S-1 Plus Oxaliplatin
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All randomized participants in the Global Cohort Pembrolizumab and SOC arms who received at least 1 dose of treatment, and all participants in the Japan-specific SOX Cohort who received at least 1 dose of treatment were included in this analysis. Per statistical analysis plan, data from the second course of pembrolizumab was not included in the safety analysis.
- reporting Status
- POSTED
- time Frame
- Up to 63 months
- title
- Number of Participants Who Discontinued Study Treatment Due to AEs
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice