TriangleNCT02552212 · OUTCOME
Percentage of Subjects With Serious Adverse Events (SAEs) During the Study
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of subjects
- Interval / dispersion
- Not reported
- Time frame
- From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)
What was measured
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is an infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above.
Analysis population: The SS consisted of all subjects who received at least 1 dose of study treatment.
Groups in this outcome
Placebo (SS)
Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Safety Set (SS).
CZP 200 mg Q2W (SS)
Certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards. Subjects formed the SS.
Placebo->OL CZP (SS)
Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.
CZP->OL CZP (SS)
Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.
SFE OL CZP 200 mg Q2W (SS)
Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
| Group | Source count |
|---|---|
| Placebo (SS) | 158 |
| CZP 200 mg Q2W (SS) | 159 |
| Placebo->OL CZP (SS) | 96 |
| CZP->OL CZP (SS) | 20 |
| SFE OL CZP 200 mg Q2W (SS) | 243 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo (SS) | 2.5 | Not reported | Not reported | Not reported | Not reported |
| CZP 200 mg Q2W (SS) | 5.0 | Not reported | Not reported | Not reported | Not reported |
| Placebo->OL CZP (SS) | 3.1 | Not reported | Not reported | Not reported | Not reported |
| CZP->OL CZP (SS) | 5.0 | Not reported | Not reported | Not reported | Not reported |
| SFE OL CZP 200 mg Q2W (SS) | 6.2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2.5
- group Id
- OG001
- value
- 5.0
- group Id
- OG002
- value
- 3.1
- group Id
- OG003
- value
- 5.0
- group Id
- OG004
- value
- 6.2
- denoms
- counts
- group Id
- OG000
- value
- 158
- group Id
- OG001
- value
- 159
- group Id
- OG002
- value
- 96
- group Id
- OG003
- value
- 20
- group Id
- OG004
- value
- 243
- units
- Participants
- description
- A serious adverse event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is an infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above.
- groups
- description
- Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Safety Set (SS).
- id
- OG000
- title
- Placebo (SS)
- description
- Certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards. Subjects formed the SS.
- id
- OG001
- title
- CZP 200 mg Q2W (SS)
- description
- Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.
- id
- OG002
- title
- Placebo->OL CZP (SS)
- description
- Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.
- id
- OG003
- title
- CZP->OL CZP (SS)
- description
- Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
- id
- OG004
- title
- SFE OL CZP 200 mg Q2W (SS)
- param Type
- NUMBER
- population Description
- The SS consisted of all subjects who received at least 1 dose of study treatment.
- reporting Status
- POSTED
- time Frame
- From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)
- title
- Percentage of Subjects With Serious Adverse Events (SAEs) During the Study
- type
- SECONDARY
- unit Of Measure
- percentage of subjects
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice