NCT04221477 · OUTCOME
Number of Participants With Adverse Events of Special Interest (AESIs)
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis · Source last updated 2026-07-21
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 Week 76
What was measured
An AE was any untoward medical occurrence in participant administered a pharmaceutical product \& which does not necessarily have to have a causal relationship with treatment. It can therefore be any unfavorable \& unintended sign (including abnormal laboratory values/ abnormal clinical test results), symptoms, or disease temporally associated with use of pharmaceutical product, whether or not considered related to product. AESIs included potential drug-induced liver injury that include an elevated alanine transaminase (ALT) \& aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice defined by Hy's law; suspected transmission of an infectious agent by study drug; infusion-related reactions (IRRs); grade 3/higher infections; any hepatitis B reactivation and progressive multifocal leukoencephalopathy (PML); drug-related neutropenia; drug-related thrombocytopenia; gastrointestinal perforations and worsening of pre-existing cardiac conditions
Analysis population: Safety evaluable population included all participants who received any part of blinded infusion of obinutuzumab or placebo and were grouped according to the treatment they actually received rather than the treatment assigned. As pre-specified in the SAP, safety data were to be provided for obinutuzumab (combined treatment groups) and placebo groups.
Groups in this outcome
Obinutuzumab
Participants received obinutuzumab, 1000 mg as an IV infusion on Day 1 and Weeks 2, 24, 26, and either Weeks 50 and 52 or Week 52 only, along with MMF and SOC therapy. Placebo was administered at Week 50 for participants not treated with obinutuzumab. Participants with adequate response at Week 76 continued to receive obinutuzumab at Week 80 and Q6M thereafter. The dose of MMF can be adjusted at the investigator's discretion beginning at Week 80.
Placebo
Participants received Obinutuzumab matching placebo as an IV infusion on Day 1 and Weeks 2, 24, 26, 50, and 52. Participants also received SOC therapy and MMF. Participants with adequate response at Week 76 continued to receive placebo at Week 80 and Q6M thereafter.
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 |
|---|
| Obinutuzumab | 136 |
|---|
| Placebo | 132 |
|---|
Reported measurements
IRRs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Obinutuzumab | 21 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3-5 infection
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Obinutuzumab | 21 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
Any Hepatitis B reactivation and PML
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Obinutuzumab | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Drug related Neutropenia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Obinutuzumab | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Drug related Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Obinutuzumab | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Gastrointestinal Perforations
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Obinutuzumab | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Worsening of pre-existing Cardiac Conditions
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Obinutuzumab | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Hy's Law
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Obinutuzumab | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Suspected Transmission of an Infectious Agent by the Study Drug
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Obinutuzumab | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 15
- title
- IRRs
- categories
- measurements
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 9
- title
- Grade 3-5 infection
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Any Hepatitis B reactivation and PML
- categories
- measurements
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 5
- title
- Drug related Neutropenia
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Drug related Thrombocytopenia
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Gastrointestinal Perforations
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- title
- Worsening of pre-existing Cardiac Conditions
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Hy's Law
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Suspected Transmission of an Infectious Agent by the Study Drug
- denoms
- counts
- group Id
- OG000
- value
- 136
- group Id
- OG001
- value
- 132
- units
- Participants
- description
- An AE was any untoward medical occurrence in participant administered a pharmaceutical product \& which does not necessarily have to have a causal relationship with treatment. It can therefore be any unfavorable \& unintended sign (including abnormal laboratory values/ abnormal clinical test results), symptoms, or disease temporally associated with use of pharmaceutical product, whether or not considered related to product. AESIs included potential drug-induced liver injury that include an elevated alanine transaminase (ALT) \& aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice defined by Hy's law; suspected transmission of an infectious agent by study drug; infusion-related reactions (IRRs); grade 3/higher infections; any hepatitis B reactivation and progressive multifocal leukoencephalopathy (PML); drug-related neutropenia; drug-related thrombocytopenia; gastrointestinal perforations and worsening of pre-existing cardiac conditions
- groups
- description
- Participants received obinutuzumab, 1000 mg as an IV infusion on Day 1 and Weeks 2, 24, 26, and either Weeks 50 and 52 or Week 52 only, along with MMF and SOC therapy. Placebo was administered at Week 50 for participants not treated with obinutuzumab. Participants with adequate response at Week 76 continued to receive obinutuzumab at Week 80 and Q6M thereafter. The dose of MMF can be adjusted at the investigator's discretion beginning at Week 80.
- id
- OG000
- title
- Obinutuzumab
- description
- Participants received Obinutuzumab matching placebo as an IV infusion on Day 1 and Weeks 2, 24, 26, 50, and 52. Participants also received SOC therapy and MMF. Participants with adequate response at Week 76 continued to receive placebo at Week 80 and Q6M thereafter.
- id
- OG001
- title
- Placebo
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety evaluable population included all participants who received any part of blinded infusion of obinutuzumab or placebo and were grouped according to the treatment they actually received rather than the treatment assigned. As pre-specified in the SAP, safety data were to be provided for obinutuzumab (combined treatment groups) and placebo groups.
- reporting Status
- POSTED
- time Frame
- Up to Week 76
- title
- Number of Participants With Adverse Events of Special Interest (AESIs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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