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Trial Outcomes & Findings for Long Term Follow-up Study for Patients Enrolled on the BP-004 Clinical Study (NCT NCT03733249)

NCT ID: NCT03733249

Last Updated: 2023-09-26

Results Overview

Overall survival (OS) in both malignant and non-malignant subpopulations at 1 and 2 years in the Intent-to-Treat (ITT) Population

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

187 participants

Primary outcome timeframe

1 and 2 years after rivogenlecleucel infusion

Results posted on

2023-09-26

Participant Flow

Study BP-404 was the long-term follow-up for patients enrolled in the BP-004 study at the Italian site as well as patients in Saudi Arabia (patients enrolled and treated in the UK who moved back after hematopoietic stem cell transplantation. The below participant flow information pertains to all patients in the BP-004 study (NCT02065869)

3 Enrolled patients did not undergo hematopoietic stem cell transplantation (HSCT)

Participant milestones

Participant milestones
Measure
Rimiducid and Rivogenlecleucel
Rimiducid: to treat uncontrolled GVHD in patients who have received rivogenlecleucel Rimiducid will be given at 0.4 mg/kg weight (intravenous infusion) No further rivogenlecleucel infusions are planned. Patients who received rivogenlecleucel in the BP-004 study will be evaluated for long-term safety and efficacy.
Overall Study
STARTED
184
Overall Study
Patients Receiving Rivogenlecleucel (BPX-501 Safety Population)
171
Overall Study
Intent-to-Treat Population
142
Overall Study
Patients Receiving at Least 1 Dose of Rimiducid
16
Overall Study
COMPLETED
149
Overall Study
NOT COMPLETED
35

Reasons for withdrawal

Reasons for withdrawal
Measure
Rimiducid and Rivogenlecleucel
Rimiducid: to treat uncontrolled GVHD in patients who have received rivogenlecleucel Rimiducid will be given at 0.4 mg/kg weight (intravenous infusion) No further rivogenlecleucel infusions are planned. Patients who received rivogenlecleucel in the BP-004 study will be evaluated for long-term safety and efficacy.
Overall Study
Death
7
Overall Study
Disease relapse
16
Overall Study
Lost to Follow-up
4
Overall Study
No rivogenlecleucel cells infused (non-evaluable)
7
Overall Study
Withdrawal by Subject
1

Baseline Characteristics

Long Term Follow-up Study for Patients Enrolled on the BP-004 Clinical Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Rimiducid and Rivogenlecleucel
n=184 Participants
Rimiducid: to treat uncontrolled GVHD in patients who have received rivogenlecleucel Rimiducid will be given at 0.4 mg/kg weight (intravenous infusion) No further rivogenlecleucel infusions are planned. Patients who received rivogenlecleucel in the BP-004 study will be evaluated for long-term safety and efficacy.
Age, Continuous
5.8 years
n=39 Participants
Age, Customized
< 2 years
43 Participants
n=39 Participants
Age, Customized
2 to < 12 years
105 Participants
n=39 Participants
Age, Customized
12 to ≤ 18 years
35 Participants
n=39 Participants
Age, Customized
18 to ≤ 26 years
1 Participants
n=39 Participants
Sex: Female, Male
Female
83 Participants
n=39 Participants
Sex: Female, Male
Male
101 Participants
n=39 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants
n=39 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
176 Participants
n=39 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=39 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=39 Participants
Race (NIH/OMB)
Asian
10 Participants
n=39 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=39 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=39 Participants
Race (NIH/OMB)
White
162 Participants
n=39 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=39 Participants
Race (NIH/OMB)
Unknown or Not Reported
11 Participants
n=39 Participants

PRIMARY outcome

Timeframe: 1 and 2 years after rivogenlecleucel infusion

Population: ITT Population: Includes all patients treated with HSCT who received rivogenlecleucel at the dose of 1×10E6 cells/kg Study BP-404 is the long-term follow-up study of patients of the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. There is a second long-term follow-up study (BP-004 UK) for patients enrolled at the UK sites. The below results include data from both the BP-404 study and the BP-004 UK study. Individual results for either study are not available.

Overall survival (OS) in both malignant and non-malignant subpopulations at 1 and 2 years in the Intent-to-Treat (ITT) Population

Outcome measures

Outcome measures
Measure
Malignant
n=62 Participants
Patients with malignant disease.
Non-malignant
n=80 Participants
Patients with non-malignant disease.
Overall Survival
2 Years · Censored
4 Participants
13 Participants
Overall Survival
1 Year · Event Occurred
8 Participants
3 Participants
Overall Survival
1 Year · Censored
3 Participants
8 Participants
Overall Survival
1 Year · At Risk [Defined as: Total participants - (Event Occurred + Censored)]
51 Participants
69 Participants
Overall Survival
2 Years · Event Occurred
8 Participants
4 Participants
Overall Survival
2 Years · At Risk [Defined as: Total participants - (Event Occurred + Censored)]
50 Participants
63 Participants

PRIMARY outcome

Timeframe: 1 and 2 years after rivogenlecleucel infusion

Population: ITT Population: Includes all patients treated with HSCT who received rivogenlecleucel at the dose of 1×10E6 cells/kg Study BP-404 is the long-term follow-up study of patients of the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. There is a second long-term follow-up study (BP-004 UK) for patients enrolled at the UK sites. The below results include data from both the BP-404 study and the BP-004 UK study. Individual results for either study are not available.

KM Parameter Estimates of disease-free survival (DFS) in the non-malignant subpopulation at 1 and 2 years in the Intent-to-Treat (ITT) Population

Outcome measures

Outcome measures
Measure
Malignant
n=80 Participants
Patients with malignant disease.
Non-malignant
Patients with non-malignant disease.
Incidence of Disease-free Survival
1 Year · Event occurred
4 Participants
—
Incidence of Disease-free Survival
1 Year · Censored
7 Participants
—
Incidence of Disease-free Survival
1 Year · At Risk [defined as: Total participants - (Event occurred + Censored)]
69 Participants
—
Incidence of Disease-free Survival
2 Years · Event occurred
5 Participants
—
Incidence of Disease-free Survival
2 Years · Censored
12 Participants
—
Incidence of Disease-free Survival
2 Years · At Risk [defined as: Total participants - (Event occurred + Censored)]
63 Participants
—

PRIMARY outcome

Timeframe: 1 and 2 years after rivogenlecleucel infusion

Population: ITT Population: Includes all patients treated with HSCT who received rivogenlecleucel at the dose of 1×10E6 cells/kg Study BP-404 is the long-term follow-up study of patients of the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. There is a second long-term follow-up study (BP-004 UK) for patients enrolled at the UK sites. The below results include data from both the BP-404 study and the BP-004 UK study. Individual results for either study are not available.

Kaplan-Meier Parameter Estimates of Relapse-free survival rate (number of patients survived without experiencing a recurrence) at the 1-year and 2-year timepoints in the Intent-to-Treat (ITT) Population in the malignant study arm (patients with a malignant reason for their transplant). ITT Population: Includes all patients treated with HSCT who received rivogenlecleucel at the dose of 1×10E6 cells/kg

Outcome measures

Outcome measures
Measure
Malignant
n=62 Participants
Patients with malignant disease.
Non-malignant
Patients with non-malignant disease.
Relapse-free Survival
1 Year · Event Occurred
12 Participants
—
Relapse-free Survival
1 Year · Censored
0 Participants
—
Relapse-free Survival
1 Year · At Risk
50 Participants
—
Relapse-free Survival
2 Years · Event Occurred
13 Participants
—
Relapse-free Survival
2 Years · Censored
1 Participants
—
Relapse-free Survival
2 Years · At Risk
48 Participants
—

Adverse Events

Rivogenlecleucel (BPX-501) Safety Population

Serious events: 52 serious events
Other events: 140 other events
Deaths: 7 deaths

Rimiducid Safety Population

Serious events: 7 serious events
Other events: 9 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Rivogenlecleucel (BPX-501) Safety Population
n=171 participants at risk
All patients who received HSCT and went on to receive any dose of rivogenlecleucel.
Rimiducid Safety Population
n=16 participants at risk
All patients who received at least 1 dose of rimiducid for the treatment of acute or chronic GvHD refractory to SoC treatment after rivogenlecleucel administration.
Infections and infestations
Septic shock
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
6.2%
1/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Blood and lymphatic system disorders
Anaemia
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
1.2%
2/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Blood and lymphatic system disorders
Cytopenia
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Blood and lymphatic system disorders
Haemolytic anaemia
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Infections and infestations
Staphylococcal bacteraemia
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
6.2%
1/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Blood and lymphatic system disorders
Histiocytosis haematophagic
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Blood and lymphatic system disorders
Neutropenia
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Blood and lymphatic system disorders
Thrombocytopenia
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Blood and lymphatic system disorders
Thrombotic microangiopathy
1.2%
2/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Cardiac disorders
Pericardial effusion
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Cardiac disorders
Pneumopericardium
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Eye disorders
Diplopia
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Gastrointestinal disorders
Diarrhoea
1.2%
2/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
6.2%
1/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Gastrointestinal disorders
Haematemesis
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Gastrointestinal disorders
Pancreatitis
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Gastrointestinal disorders
Parotid gland enlargement
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
6.2%
1/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Gastrointestinal disorders
Vomiting
1.2%
2/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
General disorders
Device damage
1.2%
2/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
General disorders
Malaise
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
General disorders
Medical device complication
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
General disorders
Pyrexia
4.1%
7/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Immune system disorders
Acute graft versus host disease
2.3%
4/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
12.5%
2/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Infections and infestations
Adenovirus infection
1.2%
2/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Infections and infestations
Bacterial sepsis
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Infections and infestations
Cytomegalovirus infection
1.8%
3/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Infections and infestations
Device related infection
1.8%
3/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Infections and infestations
Encephalitis
1.2%
2/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Infections and infestations
Escherichia infection
1.2%
2/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Infections and infestations
Gastroenteritis rotavirus
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Infections and infestations
Infection
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Infections and infestations
Klebsiella infection
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Infections and infestations
Pharyngitis
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Infections and infestations
Pseudomonas infection
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Infections and infestations
Respiratory tract infection
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Infections and infestations
Sepsis
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
6.2%
1/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Infections and infestations
Staphylococcal infection
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Infections and infestations
Staphylococcal sepsis
1.2%
2/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Infections and infestations
Varicella zoster virus infection
1.2%
2/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Injury, poisoning and procedural complications
Fall
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Juvenile chronic myelomonocytic leukaemia
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Nervous system disorders
Central nervous system lesion
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
6.2%
1/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Nervous system disorders
Encephalopathy
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
6.2%
1/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Nervous system disorders
Miller Fisher syndrome
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Nervous system disorders
Posterior reversible encephalopathy syndrome
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Renal and urinary disorders
Cystitis haemorrhagic
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Respiratory, thoracic and mediastinal disorders
Cardiopulmonary failure
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
6.2%
1/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Respiratory, thoracic and mediastinal disorders
Respiratory distress
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
6.2%
1/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Vascular disorders
Hypotension
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Vascular disorders
Pelvic venous thrombosis
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).

Other adverse events

Other adverse events
Measure
Rivogenlecleucel (BPX-501) Safety Population
n=171 participants at risk
All patients who received HSCT and went on to receive any dose of rivogenlecleucel.
Rimiducid Safety Population
n=16 participants at risk
All patients who received at least 1 dose of rimiducid for the treatment of acute or chronic GvHD refractory to SoC treatment after rivogenlecleucel administration.
Infections and infestations
Cytomegalovirus infection
19.9%
34/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Infections and infestations
Adenovirus infection
6.4%
11/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Infections and infestations
Human herpesvirus 6 infection
5.3%
9/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Immune system disorders
Acute graft versus host disease
28.1%
48/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
18.8%
3/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Skin and subcutaneous tissue disorders
Rash
12.3%
21/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Skin and subcutaneous tissue disorders
Pruritus
7.0%
12/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Gastrointestinal disorders
Diarrhea
11.7%
20/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Gastrointestinal disorders
Vomiting
11.7%
20/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Gastrointestinal disorders
Nausea
5.8%
10/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
General disorders
Pyrexia
19.3%
33/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
0.00%
0/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Immune system disorders
Chronic graft versus host disease
2.9%
5/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
6.2%
1/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Infections and infestations
Sepsis
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
6.2%
1/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Infections and infestations
Septic shock
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
6.2%
1/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Infections and infestations
Staphylococcal infection
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
6.2%
1/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Gastrointestinal disorders
Gastrointestinal hemorrhage
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
6.2%
1/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Gastrointestinal disorders
Parotid gland enlargement
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
6.2%
1/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Nervous system disorders
Central nervous system lesion
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
6.2%
1/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Nervous system disorders
Encephalopathy
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
6.2%
1/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
6.2%
1/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Respiratory, thoracic and mediastinal disorders
Respiratory distress
1.2%
2/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
6.2%
1/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Cardiac disorders
Right ventricular failure
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
6.2%
1/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Metabolism and nutrition disorders
Hypokalemia
1.2%
2/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
6.2%
1/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Psychiatric disorders
Confusional state
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
6.2%
1/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
Skin and subcutaneous tissue disorders
Skin discoloration
0.58%
1/171 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).
6.2%
1/16 • BP-404 is the long-term follow-up study of patients in the BP-004 study who were enrolled at the Italian and Saudi Arabia sites. Since a summary of AEs is not available for the long-term studies alone, the below AE data pertain to Study BP-004 (AEs assessed up to180 days post rivogenlecleucel administration for serious AEs (including all-cause mortality) and 30 days post rivogenlecleucel for non-serious AEs [30 and 7 days post rimiducid administration for serious/non-serious AEs respectively]).

Additional Information

Rivogenlecleucel Study Team

Bellicum Pharmaceuticals

Phone: (832) 384-1100

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place