Trial Outcomes & Findings for Non-Interventional Study on the Tolerability and Efficacy of IVIG (NCT NCT02303093)
NCT ID: NCT02303093
Last Updated: 2021-06-29
Results Overview
Number of patients with adverse drug reactions
Recruitment status
COMPLETED
Target enrollment
344 participants
Primary outcome timeframe
up to one year
Results posted on
2021-06-29
Participant Flow
Participant milestones
| Measure |
All Patients
All patients
|
|---|---|
|
Overall Study
STARTED
|
344
|
|
Overall Study
COMPLETED
|
344
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Non-Interventional Study on the Tolerability and Efficacy of IVIG
Baseline characteristics by cohort
| Measure |
All Patients
n=344 Participants
All patients
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
160 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
184 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
138 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
199 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to one yearNumber of patients with adverse drug reactions
Outcome measures
| Measure |
Octagam 5%
n=139 Participants
Octagam 5%
|
Octagam 10%
n=183 Participants
Octagam 10%
|
Octagam 5% and Octagam 10%, While Under Octagam 5%
n=11 Participants
Octagam 5% and Octagam 10%, while under Octagam 5%
|
Octagam 5% and Octagam 10%, While Under Octagam 10%
n=11 Participants
Octagam 5% and Octagam 10%, while under Octagam 10%
|
Octagam 10% and Panzyga, While Under Octagam 10%
n=11 Participants
Octagam 10% and Panzyga, while under Octagam 10%
|
Octagam 10% and Panzyga, While Under Panzyga
n=11 Participants
Octagam 10% and Panzyga, while under Panzyga
|
|---|---|---|---|---|---|---|
|
Adverse Drug Reactions
|
17 Participants
|
37 Participants
|
0 Participants
|
1 Participants
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to one yearPopulation: Number of patients in the safety population with the respective diagnosis who attended the respective visit. Not all patients attended respective visit.
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.
Outcome measures
| Measure |
Octagam 5%
n=60 Participants
Octagam 5%
|
Octagam 10%
n=121 Participants
Octagam 10%
|
Octagam 5% and Octagam 10%, While Under Octagam 5%
n=2 Participants
Octagam 5% and Octagam 10%, while under Octagam 5%
|
Octagam 5% and Octagam 10%, While Under Octagam 10%
Octagam 5% and Octagam 10%, while under Octagam 10%
|
Octagam 10% and Panzyga, While Under Octagam 10%
Octagam 10% and Panzyga, while under Octagam 10%
|
Octagam 10% and Panzyga, While Under Panzyga
Octagam 10% and Panzyga, while under Panzyga
|
|---|---|---|---|---|---|---|
|
Infection Occurrence
Frequency of infections · Unfavourable
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Infection Occurrence
Frequency of infections · Missing
|
33 Participants
|
24 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Infection Occurrence
Intensity of infections · Beneficial
|
20 Participants
|
55 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Infection Occurrence
Duration of infections · Beneficial
|
20 Participants
|
50 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Infection Occurrence
Duration of infections · Unchanged
|
7 Participants
|
43 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Infection Occurrence
Duration of infections · Missing
|
33 Participants
|
24 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Infection Occurrence
Frequency of infections · Beneficial
|
20 Participants
|
61 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Infection Occurrence
Frequency of infections · Unchanged
|
7 Participants
|
31 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Infection Occurrence
Intensity of infections · Unchanged
|
7 Participants
|
40 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Infection Occurrence
Intensity of infections · Unfavourable
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Infection Occurrence
Intensity of infections · Missing
|
33 Participants
|
24 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Infection Occurrence
Duration of infections · Unfavourable
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
Adverse Events
Octagam 5%
Serious events: 3 serious events
Other events: 13 other events
Deaths: 1 deaths
Octagam 10%
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Octagam 5% and Octagam 10%, While Under Octagam 5%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Octagam 5% and Octagam 10%, While Under Octagam 10%
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Octagam 10% and Panzyga, While Under Octagam 10%
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Octagam 10% and Panzyga, While Under Panzyga
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Octagam 5%
n=139 participants at risk
Octagam 5%
|
Octagam 10%
n=183 participants at risk
Octagam 10%
|
Octagam 5% and Octagam 10%, While Under Octagam 5%
n=11 participants at risk
Octagam 5% and Octagam 10%, while under Octagam 5%
|
Octagam 5% and Octagam 10%, While Under Octagam 10%
n=11 participants at risk
Octagam 5% and Octagam 10%, while under Octagam 10%
|
Octagam 10% and Panzyga, While Under Octagam 10%
n=11 participants at risk
Octagam 10% and Panzyga, while under Octagam 10%
|
Octagam 10% and Panzyga, While Under Panzyga
n=11 participants at risk
Octagam 10% and Panzyga, while under Panzyga
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiogenic shock
|
0.72%
1/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Vascular disorders
Embolism
|
0.72%
1/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Investigations
Hepatic enzyme increased
|
0.72%
1/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Vascular disorders
Thrombosis
|
0.72%
1/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Blood and lymphatic system disorders
Anaemia
|
0.72%
1/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Infections and infestations
Klebsiella infection
|
0.72%
1/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.72%
1/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.72%
1/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.72%
1/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.72%
1/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.72%
1/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Nervous system disorders
Headache
|
0.00%
0/139 • Approximately 12 months, observational study
|
0.55%
1/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.72%
1/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
Other adverse events
| Measure |
Octagam 5%
n=139 participants at risk
Octagam 5%
|
Octagam 10%
n=183 participants at risk
Octagam 10%
|
Octagam 5% and Octagam 10%, While Under Octagam 5%
n=11 participants at risk
Octagam 5% and Octagam 10%, while under Octagam 5%
|
Octagam 5% and Octagam 10%, While Under Octagam 10%
n=11 participants at risk
Octagam 5% and Octagam 10%, while under Octagam 10%
|
Octagam 10% and Panzyga, While Under Octagam 10%
n=11 participants at risk
Octagam 10% and Panzyga, while under Octagam 10%
|
Octagam 10% and Panzyga, While Under Panzyga
n=11 participants at risk
Octagam 10% and Panzyga, while under Panzyga
|
|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/139 • Approximately 12 months, observational study
|
3.8%
7/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
36.4%
4/11 • Approximately 12 months, observational study
|
36.4%
4/11 • Approximately 12 months, observational study
|
|
General disorders
Chills
|
0.00%
0/139 • Approximately 12 months, observational study
|
3.3%
6/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
General disorders
Chest discomfort
|
1.4%
2/139 • Approximately 12 months, observational study
|
1.6%
3/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
18.2%
2/11 • Approximately 12 months, observational study
|
|
General disorders
Feeling hot
|
0.00%
0/139 • Approximately 12 months, observational study
|
2.7%
5/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
General disorders
Malaise
|
0.00%
0/139 • Approximately 12 months, observational study
|
2.2%
4/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
General disorders
Influenza like illness
|
0.00%
0/139 • Approximately 12 months, observational study
|
2.2%
4/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
General disorders
PYREXIA
|
0.00%
0/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
General disorders
ASTHENIA
|
0.00%
0/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
18.2%
2/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
General disorders
FEELING COLD
|
0.00%
0/139 • Approximately 12 months, observational study
|
1.6%
3/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
General disorders
CHEST PAIN
|
0.00%
0/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
|
General disorders
FEELING OF BODY TEMPERATURE CHANGE
|
0.00%
0/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Nervous system disorders
HEADACHE
|
2.2%
3/139 • Approximately 12 months, observational study
|
10.9%
20/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
72.7%
8/11 • Approximately 12 months, observational study
|
72.7%
8/11 • Approximately 12 months, observational study
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
18.2%
2/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
0.00%
0/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Nervous system disorders
TREMOR
|
0.00%
0/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Gastrointestinal disorders
NAUSEA
|
1.4%
2/139 • Approximately 12 months, observational study
|
6.6%
12/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/139 • Approximately 12 months, observational study
|
2.7%
5/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
|
Gastrointestinal disorders
VOMITING
|
1.4%
2/139 • Approximately 12 months, observational study
|
1.6%
3/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/139 • Approximately 12 months, observational study
|
1.6%
3/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
18.2%
2/11 • Approximately 12 months, observational study
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/139 • Approximately 12 months, observational study
|
1.1%
2/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/139 • Approximately 12 months, observational study
|
1.1%
2/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
|
Gastrointestinal disorders
PARAESTHESIA ORAL
|
0.00%
0/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/139 • Approximately 12 months, observational study
|
1.6%
3/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/139 • Approximately 12 months, observational study
|
1.1%
2/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/139 • Approximately 12 months, observational study
|
0.55%
1/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
18.2%
2/11 • Approximately 12 months, observational study
|
|
Skin and subcutaneous tissue disorders
COLD SWEAT
|
0.00%
0/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/139 • Approximately 12 months, observational study
|
1.1%
2/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
1.4%
2/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
0.00%
0/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
|
Vascular disorders
FLUSHING
|
0.00%
0/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
18.2%
2/11 • Approximately 12 months, observational study
|
18.2%
2/11 • Approximately 12 months, observational study
|
|
Vascular disorders
HYPERTENSION
|
1.4%
2/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Vascular disorders
HOT FLUSH
|
0.00%
0/139 • Approximately 12 months, observational study
|
1.1%
2/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/139 • Approximately 12 months, observational study
|
1.6%
3/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/139 • Approximately 12 months, observational study
|
1.6%
3/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/139 • Approximately 12 months, observational study
|
1.1%
2/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/139 • Approximately 12 months, observational study
|
1.1%
2/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL DISCOMFORT
|
0.00%
0/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/139 • Approximately 12 months, observational study
|
1.1%
2/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
0.00%
0/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
18.2%
2/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
|
Psychiatric disorders
SLEEP DISORDER
|
0.00%
0/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
|
Cardiac disorders
CYANOSIS
|
0.00%
0/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/139 • Approximately 12 months, observational study
|
1.1%
2/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/139 • Approximately 12 months, observational study
|
0.00%
0/183 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
9.1%
1/11 • Approximately 12 months, observational study
|
0.00%
0/11 • Approximately 12 months, observational study
|
Additional Information
Dr. Bernhard Rohrbacher
Octapharma Pharmazeutika Produktionsgesm.b.H.,
Phone: +431610324182
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place