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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001931-19 | EudraCT Number |
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The aim of this study is to investigate the safety and tolerability of BI 655130 in healthy male subjects following single rising low, medium and high doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 655130 (spesolimab) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 655130 (spesolimab) | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Drug Related Adverse Events | Percentage of subjects with drug related adverse events are presented. | Adverse events reported until the end-of-trial examination; up to day 74 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Measured Concentration of BI 655130 in Plasma (Cmax) | Maximum measured concentration of BI 655130 in plasma (Cmax) is presented. | -2 hours (h) before and 0.5h, 1h, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h after drug administration |
| Area Under the Concentration-time Curve of the BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Life Science Services - Clinical Research | Antwerp | 2060 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36451029 | Derived | Joseph D, Thoma C, Haeufel T, Li X. Assessment of the Pharmacokinetics and Safety of Spesolimab, a Humanised Anti-interleukin-36 Receptor Monoclonal Antibody, in Healthy Non-Japanese and Japanese Subjects: Results from Phase I Clinical Studies. Clin Pharmacokinet. 2022 Dec;61(12):1771-1787. doi: 10.1007/s40262-022-01176-5. Epub 2022 Dec 1. |
| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
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A total of 80 subjects were planned to be included in 10 sequential dose groups, each consisting of 8 subjects (6 on BI 655130 and 2 on placebo). However, 1 additional dose group was introduced to accommodate for a dosing error administration of 0.050 mg/kg instead of 0.100 mg/kg;
A total of 78 subjects were randomised to 11 sequential dose groups (including an unplanned dose group). All subjects completed the trial according to the protocol. 3 subjects were not dosed as planned: they received 0.050 mg/kg BI 655130 instead of the planned 0.100 mg/kg BI 655130.
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.001 mg/kg BI 655130 (Dose Group 1) | Male healthy volunteers received single dose of 0.001 milligrams/kilograms (mg/kg) BI 655130 as concentrate for solution for Intravenous (IV) 30 min infusion |
| FG001 | 0.003 mg/kg BI 655130 (Dose Group 2) | Male healthy volunteers received single dose of 0.003 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| FG002 | 0.010 mg/kg BI 655130 (Dose Group 3) | Male healthy volunteers received single dose of 0.010 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| FG003 | 0.030 mg/kg BI 655130 (Dose Group 4) | Male healthy volunteers received single dose of 0.030 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| FG004 | 0.100 mg/kg BI 655130 (Dose Group 5) | Male healthy volunteers received single dose of 0.100 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| FG005 | 0.300 mg/kg BI 655130 (Dose Group 6) | Male healthy volunteers received single dose of0.300 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| FG006 | 1 mg/kg BI 655130 (Dose Group 7) | Male healthy volunteers received single dose of 1 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| FG007 | 3 mg/kg BI 655130 (Dose Group 8) | Male healthy volunteers received single dose of 3 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| FG008 | 6 mg/kg BI 655130 (Dose Group 9) | Male healthy volunteers received single dose of 6 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| FG009 | 10 mg/kg BI 655130 (Dose Group 10) | Male healthy volunteers received single dose of 10 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| FG010 | 0.050 mg/kg BI 655130 (Unplanned) | Male healthy volunteers received single dose of 0.050 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion (unit strength: 20 milligrams/milliLitres (mg/mL). This separate group (unplanned) was introduced to accommodate subjects who had been wrongly administered 0.050 mg/kg BI 655130 instead of the planned 0.100 mg/kg BI 655130 |
| FG011 | Placebo | Male healthy volunteers received single dose of matching placebo as concentrate for solution for IV 30 min infusion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.001 mg/kg BI 655130 (Dose Group 1) | Male healthy volunteers received single dose of 0.001 milligrams/kilograms (mg/kg) BI 655130 as concentrate for solution for Intravenous (IV) 30 min infusion |
| BG001 | 0.003 mg/kg BI 655130 (Dose Group 2) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects With Drug Related Adverse Events | Percentage of subjects with drug related adverse events are presented. | Treated set | Posted | Number | percentage of participants | Adverse events reported until the end-of-trial examination; up to day 74 |
|
Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Male healthy volunteers received single dose of matching placebo as concentrate for solution for IV 30 min infusion. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| C000712973 | spesolimab |
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|
Area under the concentration-time curve of the BI 655130 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented. Reliable values of AUC0-∞ could not be calculated because concentrations were too high at the last PK sample collected "1680h" after drug administration. AUC0-tz was utilized for the dose proportionality analyses instead of AUC0-∞. |
| -2 hours (h) before and 0.5h, 1h, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h after drug administration |
| Area Under the Concentration-time Curve of the BI 655130 in Plasma Over the Time Interval From 0 to the Last Measurable Plasma Concentration (AUC0-tz) | Area under the concentration-time curve of the BI 655130 in plasma over the time interval from 0 to the last measurable plasma concentration (AUC0-tz) is presented. | -2 hours (h) before and 0.5h, 1h, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h after drug administration |
Male healthy volunteers received single dose of 0.003 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| BG002 | 0.010 mg/kg BI 655130 (Dose Group 3) | Male healthy volunteers received single dose of 0.010 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| BG003 | 0.030 mg/kg BI 655130 (Dose Group 4) | Male healthy volunteers received single dose of 0.030 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| BG004 | 0.100 mg/kg BI 655130 (Dose Group 5) | Male healthy volunteers received single dose of 0.100 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| BG005 | 0.300 mg/kg BI 655130 (Dose Group 6) | Male healthy volunteers received single dose of0.300 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| BG006 | 1 mg/kg BI 655130 (Dose Group 7) | Male healthy volunteers received single dose of 1 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| BG007 | 3 mg/kg BI 655130 (Dose Group 8) | Male healthy volunteers received single dose of 3 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| BG008 | 6 mg/kg BI 655130 (Dose Group 9) | Male healthy volunteers received single dose of 6 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| BG009 | 10 mg/kg BI 655130 (Dose Group 10) | Male healthy volunteers received single dose of 10 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| BG010 | 0.050 mg/kg BI 655130 (Unplanned) | Male healthy volunteers received single dose of 0.050 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion (unit strength: 20 milligrams/milliLitres (mg/mL). This separate group (unplanned) was introduced to accommodate subjects who had been wrongly administered 0.050 mg/kg BI 655130 instead of the planned 0.100 mg/kg BI 655130 |
| BG011 | Placebo | Male healthy volunteers received single dose of matching placebo as concentrate for solution for IV 30 min infusion. |
| BG012 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | 0.010 mg/kg BI 655130 (Dose Group 3) | Male healthy volunteers received single dose of 0.010 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| OG003 | 0.030 mg/kg BI 655130 (Dose Group 4) | Male healthy volunteers received single dose of 0.030 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| OG004 | 0.100 mg/kg BI 655130 (Dose Group 5) | Male healthy volunteers received single dose of 0.100 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| OG005 | 0.300 mg/kg BI 655130 (Dose Group 6) | Male healthy volunteers received single dose of0.300 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| OG006 | 1 mg/kg BI 655130 (Dose Group 7) | Male healthy volunteers received single dose of 1 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| OG007 | 3 mg/kg BI 655130 (Dose Group 8) | Male healthy volunteers received single dose of 3 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| OG008 | 6 mg/kg BI 655130 (Dose Group 9) | Male healthy volunteers received single dose of 6 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| OG009 | 10 mg/kg BI 655130 (Dose Group 10) | Male healthy volunteers received single dose of 10 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion |
| OG010 | 0.050 mg/kg BI 655130 (Unplanned) | Male healthy volunteers received single dose of 0.050 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion (unit strength: 20 milligrams/milliLitres (mg/mL). This separate group (unplanned) was introduced to accommodate subjects who had been wrongly administered 0.050 mg/kg BI 655130 instead of the planned 0.100 mg/kg BI 655130 |
| OG011 | Placebo | Male healthy volunteers received single dose of matching placebo as concentrate for solution for IV 30 min infusion. |
|
|
| Secondary | Maximum Measured Concentration of BI 655130 in Plasma (Cmax) | Maximum measured concentration of BI 655130 in plasma (Cmax) is presented. | Descriptive pharmacokinetic analysis set (PKSD): The descriptive analysis of PK (pharmacokinetic) concentrations and parameters was based on all treated subjects who provided at least 1 PK concentration (plasma or urine) that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms/milliLitres (μg/mL) | -2 hours (h) before and 0.5h, 1h, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h after drug administration |
|
|
|
|
| Secondary | Area Under the Concentration-time Curve of the BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of the BI 655130 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented. Reliable values of AUC0-∞ could not be calculated because concentrations were too high at the last PK sample collected "1680h" after drug administration. AUC0-tz was utilized for the dose proportionality analyses instead of AUC0-∞. | Descriptive pharmacokinetic analysis set (PKSD): The descriptive analysis of PK (pharmacokinetic) concentrations and parameters was based on all treated subjects who provided at least 1 PK concentration (plasma or urine) that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms*day/milliLitres (μg*day/mL) | -2 hours (h) before and 0.5h, 1h, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h after drug administration |
|
|
|
| Secondary | Area Under the Concentration-time Curve of the BI 655130 in Plasma Over the Time Interval From 0 to the Last Measurable Plasma Concentration (AUC0-tz) | Area under the concentration-time curve of the BI 655130 in plasma over the time interval from 0 to the last measurable plasma concentration (AUC0-tz) is presented. | Descriptive pharmacokinetic analysis set (PKSD): The descriptive analysis of PK (pharmacokinetic) concentrations and parameters was based on all treated subjects who provided at least 1 PK concentration (plasma or urine) that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms*day/milliLitres (μg*day/mL) | -2 hours (h) before and 0.5h, 1h, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h after drug administration |
|
|
|
|
| 0 |
| 20 |
| 11 |
| 20 |
| EG001 | 0.001 mg/kg BI 655130 (Dose Group 1) | Male healthy volunteers received single dose of 0.001 milligrams/kilograms (mg/kg) BI 655130 as concentrate for solution for Intravenous (IV) 30 min infusion | 0 | 6 | 2 | 6 |
| EG002 | 0.003 mg/kg BI 655130 (Dose Group 2) | Male healthy volunteers received single dose of 0.003 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion | 0 | 6 | 4 | 6 |
| EG003 | 0.010 mg/kg BI 655130 (Dose Group 3) | Male healthy volunteers received single dose of 0.010 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion | 0 | 6 | 5 | 6 |
| EG004 | 0.030 mg/kg BI 655130 (Dose Group 4) | Male healthy volunteers received single dose of 0.030 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion | 0 | 6 | 5 | 6 |
| EG005 | 0.100 mg/kg BI 655130 (Dose Group 5) | Male healthy volunteers received single dose of 0.100 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion | 0 | 5 | 4 | 5 |
| EG006 | 0.300 mg/kg BI 655130 (Dose Group 6) | Male healthy volunteers received single dose of0.300 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion | 0 | 4 | 2 | 4 |
| EG007 | 1 mg/kg BI 655130 (Dose Group 7) | Male healthy volunteers received single dose of 1 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion | 0 | 6 | 5 | 6 |
| EG008 | 3 mg/kg BI 655130 (Dose Group 8) | Male healthy volunteers received single dose of 3 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion | 0 | 6 | 3 | 6 |
| EG009 | 6 mg/kg BI 655130 (Dose Group 9) | Male healthy volunteers received single dose of 6 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion | 0 | 6 | 3 | 6 |
| EG010 | 10 mg/kg BI 655130 (Dose Group 10) | Male healthy volunteers received single dose of 10 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion | 0 | 4 | 1 | 4 |
| EG011 | 0.050 mg/kg BI 655130 (Unplanned) | Male healthy volunteers received single dose of 0.050 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion (unit strength: 20 milligrams/milliLitres (mg/mL). This separate group (unplanned) was introduced to accommodate subjects who had been wrongly administered 0.050 mg/kg BI 655130 instead of the planned 0.100 mg/kg BI 655130 | 0 | 3 | 2 | 3 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Conjunctivitis bacterial | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Dose proportionality in plasma for Cmax (log-transformed scale) was explored based on the linear regression model. | Slope | 1.0207 | Standard Error of the Mean | 0.0261 | 2-Sided | 95 | 0.9668 | 1.0747 | Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope. | Superiority or Other (legacy) |
| Dose proportionality in plasma for AUC(0-tz) (log-transformed scale) was explored based on the linear regression model. | Slope | 1.0003 | Standard Error of the Mean | 0.0253 | 2-Sided | 95 | 0.9482 | 1.0525 | Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope. | Superiority or Other (legacy) |