TriangleNCT03777657 · OUTCOME
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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
- From first dose of study drug to 30 days after last dose or the initiation of a new anticancer therapy, whichever occurred first, up to the end of study; maximum treatment duration was 59.3 months in Tislelizumab and 56.8 months in the Placebo group.
What was measured
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drugs, whether related to study drugs or not. An SAE is any untoward medical occurrence that, at any dose met any of the following criteria: * Resulted in death * Was life-threatening * Required hospitalization or prolongation of existing hospitalization * Resulted in disability/incapacity * Was a congenital anomaly/birth defect * Was considered a significant medical AE by the Investigator based on medical judgement.
Analysis population: The Safety Analysis Set included all participants who received ≥ 1 dose of study drug
Groups in this outcome
Tislelizumab + Chemotherapy
Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.
Placebo + Chemotherapy
Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Tislelizumab + Chemotherapy | 498 |
| Placebo + Chemotherapy | 494 |
Reported measurements
Any TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tislelizumab + Chemotherapy | 495 | Not reported | Not reported | Not reported | Not reported |
| Placebo + Chemotherapy | 486 | Not reported | Not reported | Not reported | Not reported |
Any SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tislelizumab + Chemotherapy | 211 | Not reported | Not reported | Not reported | Not reported |
| Placebo + Chemotherapy | 179 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 495
- group Id
- OG001
- value
- 486
- title
- Any TEAE
- categories
- measurements
- group Id
- OG000
- value
- 211
- group Id
- OG001
- value
- 179
- title
- Any SAE
- denoms
- counts
- group Id
- OG000
- value
- 498
- group Id
- OG001
- value
- 494
- units
- Participants
- description
- An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drugs, whether related to study drugs or not. An SAE is any untoward medical occurrence that, at any dose met any of the following criteria: * Resulted in death * Was life-threatening * Required hospitalization or prolongation of existing hospitalization * Resulted in disability/incapacity * Was a congenital anomaly/birth defect * Was considered a significant medical AE by the Investigator based on medical judgement.
- groups
- description
- Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Tislelizumab + Chemotherapy
- description
- Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.
- id
- OG001
- title
- Placebo + Chemotherapy
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The Safety Analysis Set included all participants who received ≥ 1 dose of study drug
- reporting Status
- POSTED
- time Frame
- From first dose of study drug to 30 days after last dose or the initiation of a new anticancer therapy, whichever occurred first, up to the end of study; maximum treatment duration was 59.3 months in Tislelizumab and 56.8 months in the Placebo group.
- title
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice