TriangleNCT02399085 · OUTCOME
Severity of Treatment-emergent Adverse Events (TEAEs)
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
- Approximately 6.5 years after first participant enrolled
What was measured
Number of participants with Severity of TEAEs during MOR00208 and LEN combination therapy.
Analysis population: SAF: The SAF includes all participants who received at least one dose of MOR00208 or LEN and had at least one post-baseline safety assessment.
Groups in this outcome
Tafasitamab (MOR00208) + Lenalidomide (LEN)
MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings. On days when both study drugs were given together, LEN was administered prior to MOR00208.
| Group | Source count |
|---|---|
| Tafasitamab (MOR00208) + Lenalidomide (LEN) | 81 |
Reported measurements
Source class 1
Severe
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tafasitamab (MOR00208) + Lenalidomide (LEN) | 43 | Not reported | Not reported | Not reported | Not reported |
Moderate
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tafasitamab (MOR00208) + Lenalidomide (LEN) | 31 | Not reported | Not reported | Not reported | Not reported |
Mild
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tafasitamab (MOR00208) + Lenalidomide (LEN) | 6 | Not reported | Not reported | Not reported | Not reported |
Missing
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tafasitamab (MOR00208) + Lenalidomide (LEN) | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 43
- title
- Severe
- measurements
- group Id
- OG000
- value
- 31
- title
- Moderate
- measurements
- group Id
- OG000
- value
- 6
- title
- Mild
- measurements
- group Id
- OG000
- value
- 1
- title
- Missing
- denoms
- counts
- group Id
- OG000
- value
- 81
- units
- Participants
- description
- Number of participants with Severity of TEAEs during MOR00208 and LEN combination therapy.
- groups
- description
- MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings. On days when both study drugs were given together, LEN was administered prior to MOR00208.
- id
- OG000
- title
- Tafasitamab (MOR00208) + Lenalidomide (LEN)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- SAF: The SAF includes all participants who received at least one dose of MOR00208 or LEN and had at least one post-baseline safety assessment.
- reporting Status
- POSTED
- time Frame
- Approximately 6.5 years after first participant enrolled
- title
- Severity of Treatment-emergent Adverse Events (TEAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice