Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG
Conditions
Brief summary
Non-Interventional Study on the Tolerability and Efficacy of octagam® 10%
Detailed description
A Non-Interventional Study on the Tolerability and Efficacy of Octagam 5% or 10% or panzyga. Patients with any indication (replacement and immonomodulation) as prescribed by the treating physician. Marketed Octagam 5% or 10% or panzyga will be used according to the investigator prescription; intravenous (iv) administration.The primary objective is to detect and evaluate adverse drug reactions (ADRs) occurring during or after the administration of Octagam or panzyga in any indication, age group or treatment regimen, where a causal relationship to the administration of Octagam or panzyga is suspected.
Interventions
BIOLOGICALOctagam IVIG 5% or 10%
Octagam IVIG 5% or 10%
BIOLOGICALPanzyga
Panzyga
Sponsors
Octapharma
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Any patient who needs to be treated with a product of this class because of his/her medical condition and whom the treating physician decides to prescribe Octagam or panzyga regularly, may be included.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Drug Reactions | up to one year | Number of patients with adverse drug reactions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection Occurrence | Up to one year | Pool of PID/SID Patients: Influence of IVIG/SCIG Treatment. Frequency, intensity, and duration of infectious episodes assessed. At the last available assessment, the influence of study IVIG on the frequency, intensity, and duration of the infections. |
Countries
Austria, Canada, France, Spain, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Patients All patients | 344 |
| Total | 344 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Continuous | 59 years |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 199 Participants |
| Race (NIH/OMB) White | 138 Participants |
| Sex: Female, Male Female | 160 Participants |
| Sex: Female, Male Male | 184 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 139 | 0 / 183 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 13 / 139 | 37 / 183 | 0 / 11 | 1 / 11 | 9 / 11 | 9 / 11 |
| serious Total, serious adverse events | 3 / 139 | 1 / 183 | 0 / 11 | 0 / 11 | 1 / 11 | 0 / 11 |
Outcome results
Primary
Adverse Drug Reactions
Number of patients with adverse drug reactions
Time frame: up to one year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Octagam 5% | Adverse Drug Reactions | 17 Participants |
| Octagam 10% | Adverse Drug Reactions | 37 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 5% | Adverse Drug Reactions | 0 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 10% | Adverse Drug Reactions | 1 Participants |
| Octagam 10% and Panzyga, While Under Octagam 10% | Adverse Drug Reactions | 9 Participants |
| Octagam 10% and Panzyga, While Under Panzyga | Adverse Drug Reactions | 9 Participants |
Secondary
Infection Occurrence
Pool of PID/SID Patients: Influence of IVIG/SCIG Treatment. Frequency, intensity, and duration of infectious episodes assessed. At the last available assessment, the influence of study IVIG on the frequency, intensity, and duration of the infections.
Time frame: Up to one year
Population: Number of patients in the safety population with the respective diagnosis who attended the respective visit. Not all patients attended respective visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Octagam 5% | Infection Occurrence | Frequency of infections | Unfavourable | 0 Participants |
| Octagam 5% | Infection Occurrence | Intensity of infections | Unfavourable | 0 Participants |
| Octagam 5% | Infection Occurrence | Duration of infections | Unchanged | 7 Participants |
| Octagam 5% | Infection Occurrence | Duration of infections | Unfavourable | 0 Participants |
| Octagam 5% | Infection Occurrence | Intensity of infections | Unchanged | 7 Participants |
| Octagam 5% | Infection Occurrence | Intensity of infections | Beneficial | 20 Participants |
| Octagam 5% | Infection Occurrence | Duration of infections | Missing | 33 Participants |
| Octagam 5% | Infection Occurrence | Frequency of infections | Unchanged | 7 Participants |
| Octagam 5% | Infection Occurrence | Intensity of infections | Missing | 33 Participants |
| Octagam 5% | Infection Occurrence | Frequency of infections | Beneficial | 20 Participants |
| Octagam 5% | Infection Occurrence | Frequency of infections | Missing | 33 Participants |
| Octagam 5% | Infection Occurrence | Duration of infections | Beneficial | 20 Participants |
| Octagam 10% | Infection Occurrence | Frequency of infections | Beneficial | 61 Participants |
| Octagam 10% | Infection Occurrence | Duration of infections | Beneficial | 50 Participants |
| Octagam 10% | Infection Occurrence | Frequency of infections | Missing | 24 Participants |
| Octagam 10% | Infection Occurrence | Duration of infections | Unchanged | 43 Participants |
| Octagam 10% | Infection Occurrence | Duration of infections | Unfavourable | 4 Participants |
| Octagam 10% | Infection Occurrence | Intensity of infections | Unchanged | 40 Participants |
| Octagam 10% | Infection Occurrence | Frequency of infections | Unchanged | 31 Participants |
| Octagam 10% | Infection Occurrence | Intensity of infections | Unfavourable | 2 Participants |
| Octagam 10% | Infection Occurrence | Frequency of infections | Unfavourable | 5 Participants |
| Octagam 10% | Infection Occurrence | Duration of infections | Missing | 24 Participants |
| Octagam 10% | Infection Occurrence | Intensity of infections | Missing | 24 Participants |
| Octagam 10% | Infection Occurrence | Intensity of infections | Beneficial | 55 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 5% | Infection Occurrence | Frequency of infections | Unfavourable | 0 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 5% | Infection Occurrence | Frequency of infections | Missing | 0 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 5% | Infection Occurrence | Intensity of infections | Beneficial | 2 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 5% | Infection Occurrence | Intensity of infections | Unchanged | 0 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 5% | Infection Occurrence | Intensity of infections | Unfavourable | 0 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 5% | Infection Occurrence | Duration of infections | Missing | 0 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 5% | Infection Occurrence | Intensity of infections | Missing | 0 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 5% | Infection Occurrence | Duration of infections | Beneficial | 2 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 5% | Infection Occurrence | Duration of infections | Unchanged | 0 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 5% | Infection Occurrence | Duration of infections | Unfavourable | 0 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 5% | Infection Occurrence | Frequency of infections | Beneficial | 2 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 5% | Infection Occurrence | Frequency of infections | Unchanged | 0 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 10% | Infection Occurrence | Duration of infections | Missing | 0 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 10% | Infection Occurrence | Duration of infections | Beneficial | 0 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 10% | Infection Occurrence | Intensity of infections | Missing | 0 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 10% | Infection Occurrence | Frequency of infections | Missing | 0 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 10% | Infection Occurrence | Frequency of infections | Beneficial | 0 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 10% | Infection Occurrence | Intensity of infections | Unfavourable | 0 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 10% | Infection Occurrence | Intensity of infections | Unchanged | 0 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 10% | Infection Occurrence | Frequency of infections | Unfavourable | 0 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 10% | Infection Occurrence | Frequency of infections | Unchanged | 0 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 10% | Infection Occurrence | Duration of infections | Unchanged | 0 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 10% | Infection Occurrence | Intensity of infections | Beneficial | 0 Participants |
| Octagam 5% and Octagam 10%, While Under Octagam 10% | Infection Occurrence | Duration of infections | Unfavourable | 0 Participants |