TriangleNCT03735121 · OUTCOME
Part 2: Percentage of Participants With 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 44.7 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 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 2: Atezolizumab IV 1200 mg
Participants received atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.
Part 2: Atezolizumab SC 1875 mg
Participants received atezolizumab, 1875 mg, co-formulated with rHuPH20, as SC injection, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.
| Group | Source count |
|---|---|
| Part 2: Atezolizumab IV 1200 mg | 124 |
| Part 2: Atezolizumab SC 1875 mg | 247 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Atezolizumab IV 1200 mg | 85.5 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Atezolizumab SC 1875 mg | 89.9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 85.5
- group Id
- OG001
- value
- 89.9
- denoms
- counts
- group Id
- OG000
- value
- 124
- group Id
- OG001
- value
- 247
- 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 NCI-CTCAE, V5.0. Percentages have been rounded to one decimal place.
- groups
- description
- Participants received atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.
- id
- OG000
- title
- Part 2: Atezolizumab IV 1200 mg
- description
- Participants received atezolizumab, 1875 mg, co-formulated with rHuPH20, as SC injection, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.
- id
- OG001
- title
- Part 2: Atezolizumab SC 1875 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 44.7 months
- title
- Part 2: Percentage of Participants With AEs
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice