TriangleNCT00648739 · OUTCOME
Number Of Participants With Treatment-Emergent Adverse Events (TEAEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose through 10 weeks after the last dose
What was measured
A TEAE was defined as any event not present prior to exposure to samalizumab or any event already present that worsened in either intensity or frequency following exposure to samalizumab. A treatment-emergent serious adverse event was defined as any event that resulted in death, was immediately life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Analysis population: All participants who received at least 1 dose of samalizumab.
Groups in this outcome
Samalizumab 50 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 50 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Samalizumab 100 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Samalizumab 200 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Samalizumab 300 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 300 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Samalizumab 400 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Samalizumab 500 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Samalizumab 600 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Overall
All doses of samalizumab were individualized based on the participant's body surface area in mg/m\^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m\^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
| Group | Source count |
|---|---|
| Samalizumab 50 mg/m^2 | 4 |
| Samalizumab 100 mg/m^2 | 5 |
| Samalizumab 200 mg/m^2 | 3 |
| Samalizumab 300 mg/m^2 | 3 |
| Samalizumab 400 mg/m^2 | 3 |
| Samalizumab 500 mg/m^2 | 7 |
| Samalizumab 600 mg/m^2 | 1 |
| Overall | 26 |
Reported measurements
At Least 1 TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Samalizumab 50 mg/m^2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 100 mg/m^2 | 5 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 200 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 300 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 400 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 500 mg/m^2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 600 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Overall | 25 | Not reported | Not reported | Not reported | Not reported |
Treatment-emergent Serious Adverse Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Samalizumab 50 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 100 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 200 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 300 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 400 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 500 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 600 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Overall | 6 | Not reported | Not reported | Not reported | Not reported |
Discontinued due to Adverse Events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Samalizumab 50 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 100 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 200 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 300 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 400 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 500 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 600 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Overall | 5 | Not reported | Not reported | Not reported | Not reported |
Adverse Events Leading to Death
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Samalizumab 50 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 100 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 200 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 300 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 400 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 500 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 600 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Overall | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 25
- title
- At Least 1 TEAE
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 6
- title
- Treatment-emergent Serious Adverse Event
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 5
- title
- Discontinued due to Adverse Events
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- title
- Adverse Events Leading to Death
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 26
- units
- Participants
- description
- A TEAE was defined as any event not present prior to exposure to samalizumab or any event already present that worsened in either intensity or frequency following exposure to samalizumab. A treatment-emergent serious adverse event was defined as any event that resulted in death, was immediately life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
- groups
- description
- Participants assigned to this dose cohort received a single IV dose of samalizumab 50 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
- id
- OG000
- title
- Samalizumab 50 mg/m^2
- description
- Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
- id
- OG001
- title
- Samalizumab 100 mg/m^2
- description
- Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
- id
- OG002
- title
- Samalizumab 200 mg/m^2
- description
- Participants assigned to this dose cohort received a single IV dose of samalizumab 300 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
- id
- OG003
- title
- Samalizumab 300 mg/m^2
- description
- Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
- id
- OG004
- title
- Samalizumab 400 mg/m^2
- description
- Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
- id
- OG005
- title
- Samalizumab 500 mg/m^2
- description
- Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
- id
- OG006
- title
- Samalizumab 600 mg/m^2
- description
- All doses of samalizumab were individualized based on the participant's body surface area in mg/m\^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m\^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
- id
- OG007
- title
- Overall
- param Type
- NUMBER
- population Description
- All participants who received at least 1 dose of samalizumab.
- reporting Status
- POSTED
- time Frame
- From first dose through 10 weeks after the last dose
- title
- Number Of Participants With Treatment-Emergent Adverse Events (TEAEs)
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice