TriangleNCT02181673 · OUTCOME
Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) at Week 14
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline and Week 14
What was measured
The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary physical component score (PCS) is derived. Scales contributing most to the scoring of the SF-36 PCS include the PF, RP, BP and GH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary PCS score is also scaled from 0 to 100 with higher scores indicating better health.
Analysis population: The full analysis set (FAS) included all participants who were randomized. Here "N" (number of participants analyzed) signifies the number of participants evaluable for this outcome measure.
Groups in this outcome
Placebo
Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
Golimumab
Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
| Group | Source count |
|---|---|
| Placebo | 222 |
| Golimumab | 233 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 2.69 | 5.920 | Not reported | Not reported | Not reported |
| Golimumab | 8.65 | 7.602 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 5.920
- value
- 2.69
- group Id
- OG001
- spread
- 7.602
- value
- 8.65
- denoms
- counts
- group Id
- OG000
- value
- 222
- group Id
- OG001
- value
- 233
- units
- Participants
- description
- The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary physical component score (PCS) is derived. Scales contributing most to the scoring of the SF-36 PCS include the PF, RP, BP and GH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary PCS score is also scaled from 0 to 100 with higher scores indicating better health.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
- id
- OG000
- title
- Placebo
- description
- Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
- id
- OG001
- title
- Golimumab
- param Type
- MEAN
- population Description
- The full analysis set (FAS) included all participants who were randomized. Here "N" (number of participants analyzed) signifies the number of participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Baseline and Week 14
- title
- Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) at Week 14
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice