TriangleNCT01550003 · OUTCOME
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Permanent Withdrawal of the Investigational Medicinal Product (IMP) During the Study
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 Baseline (Week 0) up to the Final Visit (70 days after final dose of CZP) (maximum up to 12 years)
What was measured
An AE is any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP. TEAEs are defined as AEs starting on or after first administration of CZP and up to 70 days after last dose of study medication. TEAEs leading to permanent withdrawal of the IMP during the study were reported in this outcome measure.
Analysis population: Safety Set (SS) consisted of all study participants in the Enrolled Set (ES) who have received at least 1 dose of study medication.
Groups in this outcome
Any CZP Dose - Weight Group: 10 - <20 kg
Participants received CZP sc as a fixed dose based on their body weight Q2W or Q4W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
Any CZP Dose - Weight Group: 20 - <40 kg
Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
Any CZP Dose - Weight Group: >=40 kg
Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
| Group | Source count |
|---|---|
| Any CZP Dose - Weight Group: 10 - <20 kg | 18 |
| Any CZP Dose - Weight Group: 20 - <40 kg | 63 |
| Any CZP Dose - Weight Group: >=40 kg | 112 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Any CZP Dose - Weight Group: 10 - <20 kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Any CZP Dose - Weight Group: 20 - <40 kg | 9 | Not reported | Not reported | Not reported | Not reported |
| Any CZP Dose - Weight Group: >=40 kg | 16 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 16
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 63
- group Id
- OG002
- value
- 112
- units
- Participants
- description
- An AE is any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP. TEAEs are defined as AEs starting on or after first administration of CZP and up to 70 days after last dose of study medication. TEAEs leading to permanent withdrawal of the IMP during the study were reported in this outcome measure.
- groups
- description
- Participants received CZP sc as a fixed dose based on their body weight Q2W or Q4W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
- id
- OG000
- title
- Any CZP Dose - Weight Group: 10 - <20 kg
- description
- Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
- id
- OG001
- title
- Any CZP Dose - Weight Group: 20 - <40 kg
- description
- Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
- id
- OG002
- title
- Any CZP Dose - Weight Group: >=40 kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Set (SS) consisted of all study participants in the Enrolled Set (ES) who have received at least 1 dose of study medication.
- reporting Status
- POSTED
- time Frame
- From Baseline (Week 0) up to the Final Visit (70 days after final dose of CZP) (maximum up to 12 years)
- title
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Permanent Withdrawal of the Investigational Medicinal Product (IMP) During the Study
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice