NCT02661022 · OUTCOME
Number of Patients With Treatment-related Adverse Events
SL-401 in Combination With Pomalidomide and Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma · Source last updated 2024-04-17
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
- Up to 12 months
What was measured
To evaluate the safety of single agent SL-401 in an initial run-in cycle in patients with multiple myeloma
Groups in this outcome
SL-401 7 µg/kg/Day
SL-401 7 µg/kg/day in combination with pomalidomide and dexamethasone
SL-401 9 µg/kg/Day
SL-401 9 µg/kg/day in combination with pomalidomide and dexamethasone
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 |
|---|
| SL-401 7 µg/kg/Day | 7 |
|---|
| SL-401 9 µg/kg/Day | 2 |
|---|
Reported measurements
At Least 1 Treatment-Related Treatment-Emergent Adverse Event
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SL-401 7 µg/kg/Day | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| SL-401 9 µg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Fatigue
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SL-401 7 µg/kg/Day | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| SL-401 9 µg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Nausea
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SL-401 7 µg/kg/Day | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| SL-401 9 µg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Pyrexia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SL-401 7 µg/kg/Day | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| SL-401 9 µg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Hypoalbuminaemia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SL-401 7 µg/kg/Day | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| SL-401 9 µg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Chills
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SL-401 7 µg/kg/Day | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| SL-401 9 µg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Insomnia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SL-401 7 µg/kg/Day | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| SL-401 9 µg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Aspartate aminotransferase increased
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SL-401 7 µg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| SL-401 9 µg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Constipation
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SL-401 7 µg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| SL-401 9 µg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Dizziness
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SL-401 7 µg/kg/Day | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| SL-401 9 µg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Flushing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SL-401 7 µg/kg/Day | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| SL-401 9 µg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Headache
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SL-401 7 µg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| SL-401 9 µg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Hypophosphataemia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SL-401 7 µg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| SL-401 9 µg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Neutropenia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SL-401 7 µg/kg/Day | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| SL-401 9 µg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Oedema peripheral
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SL-401 7 µg/kg/Day | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| SL-401 9 µg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SL-401 7 µg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| SL-401 9 µg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 2
- title
- At Least 1 Treatment-Related Treatment-Emergent Adverse Event
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 1
- title
- Fatigue
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 1
- title
- Nausea
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- title
- Pyrexia
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- title
- Hypoalbuminaemia
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 0
- title
- Chills
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- title
- Insomnia
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- title
- Aspartate aminotransferase increased
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- title
- Constipation
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- title
- Dizziness
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- title
- Flushing
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- title
- Headache
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 2
- units
- Participants
- description
- To evaluate the safety of single agent SL-401 in an initial run-in cycle in patients with multiple myeloma
- groups
- description
- SL-401 7 µg/kg/day in combination with pomalidomide and dexamethasone
- id
- OG000
- title
- SL-401 7 µg/kg/Day
- description
- SL-401 9 µg/kg/day in combination with pomalidomide and dexamethasone
- id
- OG001
- title
- SL-401 9 µg/kg/Day
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Up to 12 months
- title
- Number of Patients With Treatment-related Adverse Events
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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