NCT02798536 · OUTCOME
Number of Grade 3-5 Adverse Events Possibly, Probably, and/or Definitely Related to the LMB-100 +/- Nab-Paclitaxel
Mesothelin-Targeted Immunotoxin LMB-100 in People With Malignant Mesothelioma · Source last updated 2022-08-23
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- adverse events
- Interval / dispersion
- Not reported
- Time frame
- 30 days after treatment
What was measured
Adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 3 is serious, Grade 4 is life-threatening, and Grade 5 is death related to adverse event.
Groups in this outcome
Dose Level 1: 170mcg LMB-100
Dose Level 1: 170mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles.
Dose Level -1: 140mcg LMB-100
Dose Level -1: 140mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles.
Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel
Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Dose Level 1: 170mcg LMB-100 | 3 |
|---|
| Dose Level -1: 140mcg LMB-100 | 7 |
|---|
| Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel | 11 |
|---|
Reported measurements
Grade 3 hyponatremia possibly related
Values in adverse events · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dose Level 1: 170mcg LMB-100 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dose Level -1: 140mcg LMB-100 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 edema limbs possibly related
Values in adverse events · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dose Level 1: 170mcg LMB-100 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dose Level -1: 140mcg LMB-100 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 hypotension probably related
Values in adverse events · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dose Level 1: 170mcg LMB-100 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dose Level -1: 140mcg LMB-100 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 CPK increased probably related
Values in adverse events · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dose Level 1: 170mcg LMB-100 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dose Level -1: 140mcg LMB-100 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 atrial fibrillation probably related
Values in adverse events · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dose Level 1: 170mcg LMB-100 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dose Level -1: 140mcg LMB-100 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 hypoalbuminemia definitely related
Values in adverse events · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dose Level 1: 170mcg LMB-100 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dose Level -1: 140mcg LMB-100 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 hyponatremia definitely related
Values in adverse events · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dose Level 1: 170mcg LMB-100 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dose Level -1: 140mcg LMB-100 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4 CPK increased probably related
Values in adverse events · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dose Level 1: 170mcg LMB-100 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dose Level -1: 140mcg LMB-100 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- Grade 3 hyponatremia possibly related
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- Grade 3 edema limbs possibly related
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- Grade 3 hypotension probably related
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- Grade 3 CPK increased probably related
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- Grade 3 atrial fibrillation probably related
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 4
- title
- Grade 3 hypoalbuminemia definitely related
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- title
- Grade 3 hyponatremia definitely related
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- Grade 4 CPK increased probably related
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 11
- units
- Participants
- description
- Adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 3 is serious, Grade 4 is life-threatening, and Grade 5 is death related to adverse event.
- groups
- description
- Dose Level 1: 170mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles.
- id
- OG000
- title
- Dose Level 1: 170mcg LMB-100
- description
- Dose Level -1: 140mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles.
- id
- OG001
- title
- Dose Level -1: 140mcg LMB-100
- description
- Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.
- id
- OG002
- title
- Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 30 days after treatment
- title
- Number of Grade 3-5 Adverse Events Possibly, Probably, and/or Definitely Related to the LMB-100 +/- Nab-Paclitaxel
- type
- SECONDARY
- unit Of Measure
- adverse events
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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