TriangleNCT02550652 · OUTCOME
Percentage of Participants With Adverse Events (AEs)
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
- From baseline to approximately 7 years and 8 months
What was measured
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs, including AEs of Special Interest were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs), Infections and Serious infections. The AEs reported do not include events after the receipt of rescue medications.
Analysis population: The safety population was defined as all participants who have received any amount of study medication. Participants are reported under the therapy they actually received.
Groups in this outcome
OBINUTUZUMAB 1000MG and MMF
Participants received obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose was up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, could use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants could receive 1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants received 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
PLACEBO and MMF
Participants received placebo matching to obinutuzumab IV infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose was up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, could use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants could receive 1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants received 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
| Group | Source count |
|---|---|
| OBINUTUZUMAB 1000MG and MMF | 64 |
| PLACEBO and MMF | 61 |
Reported measurements
Adverse Events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| OBINUTUZUMAB 1000MG and MMF | 58 | Not reported | Not reported | Not reported | Not reported |
| PLACEBO and MMF | 54 | Not reported | Not reported | Not reported | Not reported |
Grade 3 AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| OBINUTUZUMAB 1000MG and MMF | 19 | Not reported | Not reported | Not reported | Not reported |
| PLACEBO and MMF | 15 | Not reported | Not reported | Not reported | Not reported |
Grade 4 AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| OBINUTUZUMAB 1000MG and MMF | 6 | Not reported | Not reported | Not reported | Not reported |
| PLACEBO and MMF | 7 | Not reported | Not reported | Not reported | Not reported |
Grade 5 AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| OBINUTUZUMAB 1000MG and MMF | 1 | Not reported | Not reported | Not reported | Not reported |
| PLACEBO and MMF | 2 | Not reported | Not reported | Not reported | Not reported |
Serious Adverse Events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| OBINUTUZUMAB 1000MG and MMF | 16 | Not reported | Not reported | Not reported | Not reported |
| PLACEBO and MMF | 17 | Not reported | Not reported | Not reported | Not reported |
Infections
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| OBINUTUZUMAB 1000MG and MMF | 48 | Not reported | Not reported | Not reported | Not reported |
| PLACEBO and MMF | 38 | Not reported | Not reported | Not reported | Not reported |
Serious infections
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| OBINUTUZUMAB 1000MG and MMF | 5 | Not reported | Not reported | Not reported | Not reported |
| PLACEBO and MMF | 10 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 58
- group Id
- OG001
- value
- 54
- title
- Adverse Events
- categories
- measurements
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 15
- title
- Grade 3 AEs
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 7
- title
- Grade 4 AEs
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- title
- Grade 5 AEs
- categories
- measurements
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 17
- title
- Serious Adverse Events
- categories
- measurements
- group Id
- OG000
- value
- 48
- group Id
- OG001
- value
- 38
- title
- Infections
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 10
- title
- Serious infections
- denoms
- counts
- group Id
- OG000
- value
- 64
- group Id
- OG001
- value
- 61
- units
- Participants
- description
- An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs, including AEs of Special Interest were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs), Infections and Serious infections. The AEs reported do not include events after the receipt of rescue medications.
- groups
- description
- Participants received obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose was up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, could use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants could receive 1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants received 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
- id
- OG000
- title
- OBINUTUZUMAB 1000MG and MMF
- description
- Participants received placebo matching to obinutuzumab IV infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose was up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, could use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants could receive 1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants received 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
- id
- OG001
- title
- PLACEBO and MMF
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The safety population was defined as all participants who have received any amount of study medication. Participants are reported under the therapy they actually received.
- reporting Status
- POSTED
- time Frame
- From baseline to approximately 7 years and 8 months
- title
- Percentage of Participants With Adverse Events (AEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice