TriangleNCT03735121 · OUTCOME
Part 1: Percentage 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
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- From initiation of study treatment up to approximately 69 months
What was measured
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 5.0 (NCI-CTCAE, v5.0). Percentages have been rounded to one decimal place.
Analysis population: Safety-evaluable population included all participants who received at least one dose of atezolizumab (IV or SC), with participants grouped according to treatment received.
Groups in this outcome
Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg
Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection on Cycle 1 Day 1 (1 cycle=21 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg
Participants received atezolizumab, 1200 mg, co-mixed with rHuPH20, as SC injection, Q2W, on Day 1 of the first 3 cycles (Cycle 1-3=14 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg
Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection, Q3W, on Day 1 of first 3 cycles, followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 for subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
| Group | Source count |
|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | 13 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | 15 |
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | 39 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | 100 | Not reported | Not reported | Not reported | Not reported |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | 86.7 | Not reported | Not reported | Not reported | Not reported |
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | 84.6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 100
- group Id
- OG001
- value
- 86.7
- group Id
- OG002
- value
- 84.6
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 39
- units
- Participants
- description
- An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 5.0 (NCI-CTCAE, v5.0). Percentages have been rounded to one decimal place.
- groups
- description
- Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection on Cycle 1 Day 1 (1 cycle=21 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
- id
- OG000
- title
- Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg
- description
- Participants received atezolizumab, 1200 mg, co-mixed with rHuPH20, as SC injection, Q2W, on Day 1 of the first 3 cycles (Cycle 1-3=14 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
- id
- OG001
- title
- Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg
- description
- Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection, Q3W, on Day 1 of first 3 cycles, followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 for subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
- id
- OG002
- title
- Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg
- param Type
- NUMBER
- population Description
- Safety-evaluable population included all participants who received at least one dose of atezolizumab (IV or SC), with participants grouped according to treatment received.
- reporting Status
- POSTED
- time Frame
- From initiation of study treatment up to approximately 69 months
- title
- Part 1: Percentage of Participants With Adverse Events (AEs)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice