GAM 10-06: Non-Interventional Study on the Tolerability and Efficacy of IVIG
Sponsor
Octapharma (Industry)
Overall Status
Completed
CT.gov ID
NCT02303093
Collaborator
(none)
344
38
106.2
9.1
0.1
Study Details
Study Description
Brief Summary
Non-Interventional Study on the Tolerability and Efficacy of octagam® 10%
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Study Type:
Observational
Actual Enrollment
:
344 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Non-Interventional Study on the Tolerability and Efficacy of IVIG
Actual Study Start Date
:
Aug 1, 2011
Actual Primary Completion Date
:
Jun 5, 2020
Actual Study Completion Date
:
Jun 5, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Octagam Patient receiving Octagam 5% or 10% IVIG |
Biological: Octagam IVIG 5% or 10%
Octagam IVIG 5% or 10%
|
| Panzyga Patient receiving panzyga |
Biological: Panzyga
Panzyga
|
Outcome Measures
Primary Outcome Measures
- Adverse Drug Reactions [up to one year]
Number of patients with adverse drug reactions
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Octapharma Research Site | Gmunden | Austria | 17 4810 | |
| 2 | Octapharma Research Site | Graz | Austria | 22 8036 | |
| 3 | Octapharma Research Site | Klagenfurt | Austria | 35 9020 | |
| 4 | Octapharma Research Site | Oberndorf | Austria | 56 5110 | |
| 5 | Octapharma Research Site | Salzburg | Austria | 5020 | |
| 6 | Octapharma Research Site | Wien | Austria | 1090 | |
| 7 | St. Paul's Hospital | Vancouver | British Columbia | Canada | V6Z 1Y6 |
| 8 | Health Sciences Centre | Winnipeg | Manitoba | Canada | R3A 1R9 |
| 9 | Hamilton Health Sciences | Hamilton | Ontario | Canada | L8N3Z5 |
| 10 | St. Michael's Hospital | Toronto | Ontario | Canada | M5B 1W8 |
| 11 | Hospital for Sick Children | Toronto | Ontario | Canada | M5G 1X8 |
| 12 | Octapharma Research Site | Argenteuil | France | 95107 | |
| 13 | Octapharma Research Site | Bourges | France | 18020 | |
| 14 | Octapharma Research Site | Béziers | France | 34525 | |
| 15 | Octapharma Research Location | Caen | France | 14033 | |
| 16 | Octapharma Research Site | Caen | France | 14033 | |
| 17 | Octapharma Research Site | La Rochelle | France | 17019 | |
| 18 | Octapharma Research Site | Marseille | France | 13285 | |
| 19 | Octapharma Research Location | Marseille | France | 13385 | |
| 20 | Octapharma Research Site | Marseille | France | 13385 | |
| 21 | Octapharma Research Center | Marseille | France | 13825 | |
| 22 | Octapharma Research Site | Montauban | France | 82013 | |
| 23 | Octapharma Research Site | Nantes | France | 44093 | |
| 24 | Octapharma Research Site | Nevers | France | 58033 | |
| 25 | Octapharma Research Site | Pessac | France | 33064 | |
| 26 | Octapharma Research Site | Pierre-Bénite | France | 69310 | |
| 27 | Octapharma Research Site | Rennes | France | 35033 | |
| 28 | Octapharma Research Site | Toulouse | France | 31300 | |
| 29 | Octapharma Research Site | Barcelona | Spain | 08035 | |
| 30 | Octapharma Research Site | Madrid | Spain | 28040 | |
| 31 | Octapharma Research Location | Madrid | Spain | 28041 | |
| 32 | Octapharma Research Site | Madrid | Spain | 28041 | |
| 33 | Octapharma Research Site | Madrid | Spain | 28046 | |
| 34 | Octapharma Research Site | Leeds | United Kingdom | LS97TF | |
| 35 | Octapharma Research Site | London | United Kingdom | E1 1BB | |
| 36 | Octapharma Research Site | London | United Kingdom | NW33QG | |
| 37 | Octapharma Research Site | Plymouth | United Kingdom | PL68DH | |
| 38 | Octapharma Research Site | Stafford | United Kingdom | ST16 3SA |
Sponsors and Collaborators
- Octapharma
Investigators
- Study Director: Lidia Cosentino, Octapharma
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Octapharma
ClinicalTrials.gov Identifier:
NCT02303093
Other Study ID Numbers:
- GAM 10-06
First Posted:
Nov 27, 2014
Last Update Posted:
Jun 29, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | All Patients |
|---|---|
| Arm/Group Description | All patients |
| Period Title: Overall Study | |
| STARTED | 344 |
| COMPLETED | 344 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | All Patients |
|---|---|
| Arm/Group Description | All patients |
| Overall Participants | 344 |
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
59
|
| Sex: Female, Male (Count of Participants) | |
| Female |
160
46.5%
|
| Male |
184
53.5%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
3
0.9%
|
| Asian |
1
0.3%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
3
0.9%
|
| White |
138
40.1%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
199
57.8%
|
Outcome Measures
| Title | Adverse Drug Reactions |
|---|---|
| Description | Number of patients with adverse drug reactions |
| Time Frame | up to one year |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Octagam 5% | Octagam 10% | Octagam 5% and Octagam 10%, While Under Octagam 5% | Octagam 5% and Octagam 10%, While Under Octagam 10% | Octagam 10% and Panzyga, While Under Octagam 10% | Octagam 10% and Panzyga, While Under Panzyga |
|---|---|---|---|---|---|---|
| Arm/Group Description | Octagam 5% | Octagam 10% | Octagam 5% and Octagam 10%, while under Octagam 5% | Octagam 5% and Octagam 10%, while under Octagam 10% | Octagam 10% and Panzyga, while under Octagam 10% | Octagam 10% and Panzyga, while under Panzyga |
| Measure Participants | 139 | 183 | 11 | 11 | 11 | 11 |
| Count of Participants [Participants] |
17
4.9%
|
37
NaN
|
0
NaN
|
1
NaN
|
9
NaN
|
9
NaN
|
| Title | Infection Occurrence |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of patients in the safety population with the respective diagnosis who attended the respective visit. Not all patients attended respective visit. |
| Arm/Group Title | Octagam 5% | Octagam 10% | Octagam 5% and Octagam 10% | Octagam 10% and Panzyga |
|---|---|---|---|---|
| Arm/Group Description | Octagam 5% | Octagam 10% | Panzyga | Octagam 10% and Panzyga |
| Measure Participants | 60 | 121 | 2 | 0 |
| Beneficial |
20
5.8%
|
61
NaN
|
2
NaN
|
0
NaN
|
| Unchanged |
7
2%
|
31
NaN
|
0
NaN
|
0
NaN
|
| Unfavourable |
0
0%
|
5
NaN
|
0
NaN
|
0
NaN
|
| Missing |
33
9.6%
|
24
NaN
|
0
NaN
|
0
NaN
|
| Beneficial |
20
5.8%
|
55
NaN
|
2
NaN
|
0
NaN
|
| Unchanged |
7
2%
|
40
NaN
|
0
NaN
|
0
NaN
|
| Unfavourable |
0
0%
|
2
NaN
|
0
NaN
|
0
NaN
|
| Missing |
33
9.6%
|
24
NaN
|
0
NaN
|
0
NaN
|
| Beneficial |
20
5.8%
|
50
NaN
|
2
NaN
|
0
NaN
|
| Unchanged |
7
2%
|
43
NaN
|
0
NaN
|
0
NaN
|
| Unfavourable |
0
0%
|
4
NaN
|
0
NaN
|
0
NaN
|
| Missing |
33
9.6%
|
24
NaN
|
0
NaN
|
0
NaN
|
Adverse Events
| Time Frame | Approximately 12 months, observational study | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||
| Arm/Group Title | Octagam 5% | Octagam 10% | Octagam 5% and Octagam 10%, While Under Octagam 5% | Octagam 5% and Octagam 10%, While Under Octagam 10% | Octagam 10% and Panzyga, While Under Octagam 10% | Octagam 10% and Panzyga, While Under Panzyga | ||||||
| Arm/Group Description | Octagam 5% | Octagam 10% | Octagam 5% and Octagam 10%, while under Octagam 5% | Octagam 5% and Octagam 10%, while under Octagam 10% | Octagam 10% and Panzyga, while under Octagam 10% | Octagam 10% and Panzyga, while under Panzyga | ||||||
All Cause Mortality |
||||||||||||
| Octagam 5% | Octagam 10% | Octagam 5% and Octagam 10%, While Under Octagam 5% | Octagam 5% and Octagam 10%, While Under Octagam 10% | Octagam 10% and Panzyga, While Under Octagam 10% | Octagam 10% and Panzyga, While Under Panzyga | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/139 (0.7%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||||
Serious Adverse Events |
||||||||||||
| Octagam 5% | Octagam 10% | Octagam 5% and Octagam 10%, While Under Octagam 5% | Octagam 5% and Octagam 10%, While Under Octagam 10% | Octagam 10% and Panzyga, While Under Octagam 10% | Octagam 10% and Panzyga, While Under Panzyga | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/139 (2.2%) | 1/183 (0.5%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/11 (0%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| Anaemia | 1/139 (0.7%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||||
| Cardiac disorders | ||||||||||||
| Cardiogenic shock | 1/139 (0.7%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||||
| Infections and infestations | ||||||||||||
| Klebsiella infection | 1/139 (0.7%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||||
| Investigations | ||||||||||||
| Hepatic enzyme increased | 1/139 (0.7%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||||
| Metabolism and nutrition disorders | ||||||||||||
| Fluid overload | 1/139 (0.7%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||||
| Nervous system disorders | ||||||||||||
| Headache | 0/139 (0%) | 1/183 (0.5%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Acute pulmonary oedema | 1/139 (0.7%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||||
| Dyspnoea | 1/139 (0.7%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||||
| Lung disorder | 1/139 (0.7%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||||
| Respiratory distress | 1/139 (0.7%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||||
| Pulmonary embolism | 1/139 (0.7%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | 1/11 (9.1%) | ||||||
| Vascular disorders | ||||||||||||
| Embolism | 1/139 (0.7%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||||
| Thrombosis | 1/139 (0.7%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
| Octagam 5% | Octagam 10% | Octagam 5% and Octagam 10%, While Under Octagam 5% | Octagam 5% and Octagam 10%, While Under Octagam 10% | Octagam 10% and Panzyga, While Under Octagam 10% | Octagam 10% and Panzyga, While Under Panzyga | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/139 (9.4%) | 37/183 (20.2%) | 0/11 (0%) | 1/11 (9.1%) | 9/11 (81.8%) | 9/11 (81.8%) | ||||||
| Cardiac disorders | ||||||||||||
| CYANOSIS | 0/139 (0%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/11 (0%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| NAUSEA | 2/139 (1.4%) | 12/183 (6.6%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | 1/11 (9.1%) | ||||||
| DIARRHOEA | 0/139 (0%) | 5/183 (2.7%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | ||||||
| VOMITING | 2/139 (1.4%) | 3/183 (1.6%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | ||||||
| ABDOMINAL PAIN UPPER | 0/139 (0%) | 3/183 (1.6%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 2/11 (18.2%) | ||||||
| ABDOMINAL DISCOMFORT | 0/139 (0%) | 2/183 (1.1%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | 1/11 (9.1%) | ||||||
| DYSPEPSIA | 0/139 (0%) | 2/183 (1.1%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||||
| ABDOMINAL PAIN | 0/139 (0%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | ||||||
| PARAESTHESIA ORAL | 0/139 (0%) | 0/183 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/11 (0%) | ||||||
| General disorders | ||||||||||||
| Fatigue | 0/139 (0%) | 7/183 (3.8%) | 0/11 (0%) | 0/11 (0%) | 4/11 (36.4%) | 4/11 (36.4%) | ||||||
| Chills | 0/139 (0%) | 6/183 (3.3%) | 0/11 (0%) | 1/11 (9.1%) | 1/11 (9.1%) | 0/11 (0%) | ||||||
| Chest discomfort | 2/139 (1.4%) | 3/183 (1.6%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | 2/11 (18.2%) | ||||||
| Feeling hot | 0/139 (0%) | 5/183 (2.7%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/11 (0%) | ||||||
| Malaise | 0/139 (0%) | 4/183 (2.2%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||||
| Influenza like illness | 0/139 (0%) | 4/183 (2.2%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||||
| PYREXIA | 0/139 (0%) | 0/183 (0%) | 0/11 (0%) | 1/11 (9.1%) | 1/11 (9.1%) | 0/11 (0%) | ||||||
| ASTHENIA | 0/139 (0%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 2/11 (18.2%) | 0/11 (0%) | ||||||
| FEELING COLD | 0/139 (0%) | 3/183 (1.6%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||||
| CHEST PAIN | 0/139 (0%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | ||||||
| FEELING OF BODY TEMPERATURE CHANGE | 0/139 (0%) | 0/183 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/11 (0%) | ||||||
| Immune system disorders | ||||||||||||
| HYPERSENSITIVITY | 0/139 (0%) | 2/183 (1.1%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||||
| Infections and infestations | ||||||||||||
| LOWER RESPIRATORY TRACT INFECTION | 0/139 (0%) | 2/183 (1.1%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||||
| Investigations | ||||||||||||
| BLOOD GLUCOSE INCREASED | 0/139 (0%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/11 (0%) | ||||||
| Metabolism and nutrition disorders | ||||||||||||
| DECREASED APPETITE | 0/139 (0%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/11 (0%) | ||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||
| PAIN IN EXTREMITY | 0/139 (0%) | 3/183 (1.6%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | ||||||
| BACK PAIN | 0/139 (0%) | 3/183 (1.6%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||||
| ARTHRALGIA | 0/139 (0%) | 2/183 (1.1%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||||
| MUSCLE SPASMS | 0/139 (0%) | 2/183 (1.1%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||||
| MUSCULOSKELETAL DISCOMFORT | 0/139 (0%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | ||||||
| Nervous system disorders | ||||||||||||
| HEADACHE | 3/139 (2.2%) | 20/183 (10.9%) | 0/11 (0%) | 0/11 (0%) | 8/11 (72.7%) | 8/11 (72.7%) | ||||||
| DIZZINESS | 0/139 (0%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | 1/11 (9.1%) | ||||||
| PARAESTHESIA | 0/139 (0%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 2/11 (18.2%) | 0/11 (0%) | ||||||
| DISTURBANCE IN ATTENTION | 0/139 (0%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/11 (0%) | ||||||
| LETHARGY | 0/139 (0%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/11 (0%) | ||||||
| TREMOR | 0/139 (0%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/11 (0%) | ||||||
| Psychiatric disorders | ||||||||||||
| INSOMNIA | 0/139 (0%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 2/11 (18.2%) | 1/11 (9.1%) | ||||||
| SLEEP DISORDER | 0/139 (0%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | ||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| DYSPHONIA | 0/139 (0%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | 1/11 (9.1%) | ||||||
| Skin and subcutaneous tissue disorders | ||||||||||||
| PRURITUS | 0/139 (0%) | 3/183 (1.6%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/11 (0%) | ||||||
| HYPERHIDROSIS | 0/139 (0%) | 2/183 (1.1%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/11 (0%) | ||||||
| URTICARIA | 0/139 (0%) | 1/183 (0.5%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | 2/11 (18.2%) | ||||||
| COLD SWEAT | 0/139 (0%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | ||||||
| ERYTHEMA | 0/139 (0%) | 2/183 (1.1%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||||
| RASH PRURITIC | 2/139 (1.4%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||||
| RASH | 0/139 (0%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | 1/11 (9.1%) | ||||||
| RASH ERYTHEMATOUS | 0/139 (0%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | ||||||
| Vascular disorders | ||||||||||||
| FLUSHING | 0/139 (0%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 2/11 (18.2%) | 2/11 (18.2%) | ||||||
| HYPERTENSION | 2/139 (1.4%) | 0/183 (0%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/11 (0%) | ||||||
| HOT FLUSH | 0/139 (0%) | 2/183 (1.1%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) | ||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Bernhard Rohrbacher |
|---|---|
| Organization | Octapharma Pharmazeutika Produktionsgesm.b.H., |
| Phone | +431610324182 |
| bernhard.rohrbacher@octapharma.com |
Responsible Party:
Octapharma
ClinicalTrials.gov Identifier:
NCT02303093
Other Study ID Numbers:
- GAM 10-06
First Posted:
Nov 27, 2014
Last Update Posted:
Jun 29, 2021
Last Verified:
Jun 1, 2021