TriangleNCT02609828 · OUTCOME
Number of Participants With Laboratory Abnormalities (Abnormal Baseline)
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
- Baseline (Day 1, before dosing) up to Week 48
What was measured
Laboratory abnormality criteria included: HGB; hematocrit; erythrocytes \< 0.8\* LLN; erythrocyte mean corpuscular volume/HGB/ HGB concentration, erythrocytes distribution width \<0.9\*LLN, \>1.1\*upper limit of normal (ULN); platelets \<0.5\*LLN,\>1.75\* ULN; leukocytes \<0.6\*LLN, \>1.5\*ULN; lymphocytes, neutrophils \<0.8\*LLN, \>1.2\*ULN; basophils, eosinophils, monocytes \>1.2\*ULN; activated partial thromboplastin time, prothrombin time \>1.1\*ULN; bilirubin\>1.5\*ULN; aspartate AT, alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase \>3.0\*ULN; protein; albumin\<0.8\*LLN, \>1.2\*ULN; urea nitrogen, cholesterol, triglycerides \>1.3\*ULN; urate \>1.2\*ULN; sodium \<0.95\*LLN,\>1.05\*ULN; potassium, chloride, calcium, magnesium, bicarbonate \<0.9\*LLN, \>1.1\*ULN; phosphate \<0.8\*LLN, \>1.2\*ULN; glucose \<0.6\*LLN, \>1.5\*ULN; creatine kinase \>2.0\*ULN.
Analysis population: The safety analysis set was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants with an abnormal baseline with at least one observation of the given laboratory test while on the study. There were no participants in reporting arm "Tanezumab10/20 mg", who met the criteria for data collection and analysis of this outcome measure.
Groups in this outcome
Placebo
Participants received placebo matched to tanezumab SC once every 8 weeks for 24 weeks.
Tanezumab 10 mg
Participants in this discontinued treatment arm, received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and completed their treatment before the amendment.
Tanezumab 10/20 mg
Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks.
Tanezumab 20 mg
Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks.
| Group | Source count |
|---|---|
| Placebo | 38 |
| Tanezumab 10 mg | 8 |
| Tanezumab 10/20 mg | 0 |
| Tanezumab 20 mg | 46 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 15 | Not reported | Not reported | Not reported | Not reported |
| Tanezumab 10 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Tanezumab 20 mg | 14 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 2
- group Id
- OG003
- value
- 14
- denoms
- counts
- group Id
- OG000
- value
- 38
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 46
- units
- Participants
- description
- Laboratory abnormality criteria included: HGB; hematocrit; erythrocytes \< 0.8\* LLN; erythrocyte mean corpuscular volume/HGB/ HGB concentration, erythrocytes distribution width \<0.9\*LLN, \>1.1\*upper limit of normal (ULN); platelets \<0.5\*LLN,\>1.75\* ULN; leukocytes \<0.6\*LLN, \>1.5\*ULN; lymphocytes, neutrophils \<0.8\*LLN, \>1.2\*ULN; basophils, eosinophils, monocytes \>1.2\*ULN; activated partial thromboplastin time, prothrombin time \>1.1\*ULN; bilirubin\>1.5\*ULN; aspartate AT, alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase \>3.0\*ULN; protein; albumin\<0.8\*LLN, \>1.2\*ULN; urea nitrogen, cholesterol, triglycerides \>1.3\*ULN; urate \>1.2\*ULN; sodium \<0.95\*LLN,\>1.05\*ULN; potassium, chloride, calcium, magnesium, bicarbonate \<0.9\*LLN, \>1.1\*ULN; phosphate \<0.8\*LLN, \>1.2\*ULN; glucose \<0.6\*LLN, \>1.5\*ULN; creatine kinase \>2.0\*ULN.
- groups
- description
- Participants received placebo matched to tanezumab SC once every 8 weeks for 24 weeks.
- id
- OG000
- title
- Placebo
- description
- Participants in this discontinued treatment arm, received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and completed their treatment before the amendment.
- id
- OG001
- title
- Tanezumab 10 mg
- description
- Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks.
- id
- OG002
- title
- Tanezumab 10/20 mg
- description
- Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks.
- id
- OG003
- title
- Tanezumab 20 mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The safety analysis set was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants with an abnormal baseline with at least one observation of the given laboratory test while on the study. There were no participants in reporting arm "Tanezumab10/20 mg", who met the criteria for data collection and analysis of this outcome measure.
- reporting Status
- POSTED
- time Frame
- Baseline (Day 1, before dosing) up to Week 48
- title
- Number of Participants With Laboratory Abnormalities (Abnormal Baseline)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice