Trial Outcomes & Findings for An Open-label, Multi-center Clinical Trial of Eculizumab in Adult Patients With Atypical Hemolytic-uremic Syndrome (NCT NCT01194973)
NCT ID: NCT01194973
Last Updated: 2017-05-30
Results Overview
Proportion of Patients with Complete TMA response was determined and defined by normalization of hematological parameters (platelet count and LDH) and preservation of renal function (defined as \< 25% increase in serum creatinine from baseline) which were sustained for at least two consecutive measurements obtained at least four weeks apart.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Through 26 weeks
Results posted on
2017-05-30
Participant Flow
A total of 44 patients diagnosed with aHUS signed the informed consent and of these, 41 patients were treated. Three patients were excluded from the study due to failed screening procedure and did not receive eculizumab.
At screening, patients had to have signs or symptoms of hemolysis; serum creatinine level ≥ ULN and platelet count \< LLN
Participant milestones
| Measure |
Eculizumab
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
|
|---|---|
|
Screening Period
STARTED
|
44
|
|
Screening Period
COMPLETED
|
41
|
|
Screening Period
NOT COMPLETED
|
3
|
|
26 Week Treatment Period
STARTED
|
41
|
|
26 Week Treatment Period
COMPLETED
|
38
|
|
26 Week Treatment Period
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Eculizumab
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
|
|---|---|
|
Screening Period
Screen Failure
|
3
|
|
26 Week Treatment Period
Adverse Event
|
1
|
|
26 Week Treatment Period
Lack of Efficacy
|
1
|
|
26 Week Treatment Period
Pregnancy
|
1
|
Baseline Characteristics
An Open-label, Multi-center Clinical Trial of Eculizumab in Adult Patients With Atypical Hemolytic-uremic Syndrome
Baseline characteristics by cohort
| Measure |
Eculizumab
n=41 Participants
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
|
|---|---|
|
Age, Continuous
|
40.3 Years
STANDARD_DEVIATION 15.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through 26 weeksPopulation: The tabulations of the proportions of patients with Complete TMA Response through 26 weeks were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.
Proportion of Patients with Complete TMA response was determined and defined by normalization of hematological parameters (platelet count and LDH) and preservation of renal function (defined as \< 25% increase in serum creatinine from baseline) which were sustained for at least two consecutive measurements obtained at least four weeks apart.
Outcome measures
| Measure |
Eculizumab
n=41 Participants
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
|
|---|---|
|
Percentage of Patients With Complete TMA Response
|
73.2 Percentage of Participants
Interval 57.1 to 85.8
|
PRIMARY outcome
Timeframe: Through 26 weeksPopulation: The tabulations of the proportions of patients with Modified Complete TMA Response through 26 weeks were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.
Proportion of Patients with Modified Complete TMA response through 26 weeks of treatment was determined and defined by normalization of hematological parameters (platelet count and LDH) and improvement in renal function (defined as ≥ 25% reduction from the baseline value in serum creatinine, which were sustained for at least two consecutive measurements obtained at least four weeks apart.
Outcome measures
| Measure |
Eculizumab
n=41 Participants
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
|
|---|---|
|
Percentage of Patients With Modified Complete TMA Response
|
56.1 Percentage of Participants
Interval 39.7 to 71.5
|
SECONDARY outcome
Timeframe: Through 26 weeksPopulation: The tabulations of the proportions of patients with Complete Hematologic Response through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.
Proportion of Patients with Complete Hematologic response through end of study was determined and defined by normalization of platelet count and LDH sustained for at least two consecutive measurements obtained at least four weeks apart.
Outcome measures
| Measure |
Eculizumab
n=41 Participants
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
|
|---|---|
|
Percentage of Patients With Complete Hematologic Response
|
87.8 Percentage of Participants
Interval 73.8 to 95.9
|
SECONDARY outcome
Timeframe: Through 26 weeksPopulation: The tabulations of the proportions of patients with Platelet Count Normalization through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.
Proportion of Patients with Platelet Count Normalization through 26 weeks of treatment was determined and defined as the platelet count observed to be ≥ 150 x 109/L on at least two consecutive measurements which span a period of at least four weeks
Outcome measures
| Measure |
Eculizumab
n=41 Participants
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
|
|---|---|
|
Percentage of Patients With Platelet Count Normalization
|
97.6 Percentage of Participants
Interval 87.1 to 99.9
|
SECONDARY outcome
Timeframe: Through 26 weeksPopulation: The tabulations of the proportions of patients with Estimated Glomerular Filtration Rate (eGFR) Improvement through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.
Proportion of Patients with Estimated Glomerular Filtration Rate (eGFR) Improvement was determined and defined as an increase in eGFR by ≥ 15 mL/min/1.73m\^2 from baseline, sustained for at least two consecutive measurements obtained at least four weeks apart.
Outcome measures
| Measure |
Eculizumab
n=41 Participants
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
|
|---|---|
|
Percentage of Patients With Estimated Glomerular Filtration Rate (eGFR) Improvement
|
53.7 Percentage of Participants
Interval 37.4 to 69.3
|
SECONDARY outcome
Timeframe: Through 26 weeksPopulation: Change from baseline platelet counts were analyzed for the ITT population using a repeated measures Analysis of variance (ANOVA) model. The estimated LS means of change from baseline at each post-baseline visit alongside with 95% CIs and P-values were calculated, as were the parameter estimates for the covariates and their associated P-values.
Outcome measures
| Measure |
Eculizumab
n=41 Participants
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
|
|---|---|
|
Platelet Count Change From Baseline to 26 Weeks
|
117.68 10^9 cells/L
Interval 92.77 to 142.59
|
SECONDARY outcome
Timeframe: Through End of Study, Median Exposure 52 WeeksPopulation: The tabulations of the proportions of patients with Complete TMA Response through end of study were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.
Proportion of Patients with Complete TMA response through end of study was determined and defined by normalization of hematological parameters (platelet count and LDH) and preservation of renal function (defined as \< 25% increase in serum creatinine from baseline) which were sustained for at least two consecutive measurements obtained at least four weeks apart.
Outcome measures
| Measure |
Eculizumab
n=41 Participants
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
|
|---|---|
|
Percentage of Patients With Complete TMA Response
|
80.5 Percentage of Participants
Interval 65.1 to 91.2
|
SECONDARY outcome
Timeframe: Through End of Study, Median Exposure 52 WeeksPopulation: The tabulations of the proportions of patients with Modified Complete TMA Response through end of study were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.
Proportion of Patients with Modified Complete TMA response through end of study was determined and defined by normalization of hematological parameters (platelet count and LDH) and improvement in renal function (defined as ≥ 25% reduction from the baseline value in serum creatinine, which were sustained for at least two consecutive measurements obtained at least four weeks apart.
Outcome measures
| Measure |
Eculizumab
n=41 Participants
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
|
|---|---|
|
Percentage of Patients With Modified Complete TMA Response
|
63.4 Percentage of Participants
Interval 46.9 to 77.9
|
SECONDARY outcome
Timeframe: Through End of Study, Median Exposure 52 WeeksPopulation: The tabulations of the proportions of patients with Complete Hematologic Response through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.
Proportion of Patients with Complete Hematologic response through end of study of treatment was determined and defined by normalization of platelet count and LDH sustained for at least two consecutive measurements obtained at least four weeks apart.
Outcome measures
| Measure |
Eculizumab
n=41 Participants
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
|
|---|---|
|
Percentage of Patients With Complete Hematologic Response
|
97.6 Percentage of Participants
Interval 87.1 to 99.9
|
SECONDARY outcome
Timeframe: Through End of Study, Median Exposure 52 WeeksPopulation: The tabulations of the proportions of patients with Platelet Count Normalization through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.
Proportion of Patients with Platelet Count Normalization through end of study of treatment was determined and defined as the platelet count observed to be ≥ 150 x 109/L on at least two consecutive measurements which span a period of at least four weeks
Outcome measures
| Measure |
Eculizumab
n=41 Participants
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
|
|---|---|
|
Percentage of Patients With Platelet Count Normalization
|
100.0 Percentage of Participants
Interval 91.4 to 100.0
|
SECONDARY outcome
Timeframe: Through End of Study, Median Exposure 52 WeeksPopulation: The tabulations of the proportions of patients with Estimated Glomerular Filtration Rate (eGFR) Improvement through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized for each parameter.
Proportion of Patients with Estimated Glomerular Filtration Rate (eGFR) Improvement was determined and defined as an increase in eGFR by ≥ 15 mL/min/1.73m\^2 from baseline sustained for at least two consecutive measurements obtained at least four weeks apart
Outcome measures
| Measure |
Eculizumab
n=41 Participants
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
|
|---|---|
|
Percentage of Patients With Estimated Glomerular Filtration Rate (eGFR) Improvement
|
61.0 Percentage of Participants
Interval 44.5 to 75.8
|
SECONDARY outcome
Timeframe: Through 52 WeeksPopulation: Change from baseline platelet counts were analyzed for the ITT population using a repeated measures ANOVA model. The estimated LS means of change from baseline at each post-baseline visit alongside with 95% CIs and P-values were calculated, as were the parameter estimates for the covariates and their associated P-values.
Outcome measures
| Measure |
Eculizumab
n=41 Participants
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
|
|---|---|
|
Platelet Count Change From Baseline to 52 Weeks
|
102.49 10^9 cells/L
Interval 68.15 to 136.82
|
Adverse Events
Eculizumab
Serious events: 19 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Eculizumab
n=41 participants at risk
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
|
|---|---|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
General disorders
Medical device complication
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Immune system disorders
Kidney transplant rejection
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
Bronchitis
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
Device related infection
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
Device related sepsis
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
Genitourinary tract gonococcal infection
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
Meningitis meningococcal
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
Meningococcal sepsis
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
Pneumonia
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
Pyelonephritis
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
Shunt infection
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Nervous system disorders
Convulsion
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Nervous system disorders
Haemorrhage intracranial
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Nervous system disorders
Paraesthesia
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Renal and urinary disorders
Renal failure acute
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Renal and urinary disorders
Renal failure chronic
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Renal and urinary disorders
Renal impairment
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Renal and urinary disorders
Renal vessel disorder
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Vascular disorders
Hypertension
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Vascular disorders
Hypertensive crisis
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Vascular disorders
Venous thrombosis
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
Other adverse events
| Measure |
Eculizumab
n=41 participants at risk
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
17.1%
7/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Blood and lymphatic system disorders
EOSINOPHILIA
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
12.2%
5/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
7.3%
3/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Blood and lymphatic system disorders
SPONTANEOUS HAEMATOMA
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Cardiac disorders
ANGINA PECTORIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Cardiac disorders
CARDIOMYOPATHY
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Cardiac disorders
PALPITATIONS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Cardiac disorders
TACHYCARDIA
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Ear and labyrinth disorders
EAR PAIN
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Ear and labyrinth disorders
TINNITUS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Ear and labyrinth disorders
TYMPANIC MEMBRANE PERFORATION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Ear and labyrinth disorders
VERTIGO
|
7.3%
3/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Endocrine disorders
HYPERPARATHYROIDISM
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Eye disorders
CONJUNCTIVITIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Eye disorders
EYE INFLAMMATION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Eye disorders
LACRIMATION INCREASED
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Eye disorders
RETINOPATHY HYPERTENSIVE
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Eye disorders
UVEITIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Eye disorders
VISION BLURRED
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
7.3%
3/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Gastrointestinal disorders
CONSTIPATION
|
7.3%
3/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Gastrointestinal disorders
DIARRHOEA
|
31.7%
13/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Gastrointestinal disorders
DRY MOUTH
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Gastrointestinal disorders
DYSPEPSIA
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Gastrointestinal disorders
DYSPHAGIA
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Gastrointestinal disorders
ENTERITIS
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDER
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Gastrointestinal disorders
GASTROINTESTINAL PAIN
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Gastrointestinal disorders
GINGIVAL HYPERTROPHY
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Gastrointestinal disorders
NAUSEA
|
12.2%
5/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Gastrointestinal disorders
ODYNOPHAGIA
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Gastrointestinal disorders
STOMATITIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Gastrointestinal disorders
VOMITING
|
14.6%
6/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
General disorders
ASTHENIA
|
14.6%
6/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
General disorders
CALCINOSIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
General disorders
CATHETER SITE DISCHARGE
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
General disorders
CATHETER SITE ERYTHEMA
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
General disorders
CATHETER SITE PRURITUS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
General disorders
CHEST DISCOMFORT
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
General disorders
CHEST PAIN
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
General disorders
CHILLS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
General disorders
DEVICE OCCLUSION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
General disorders
FATIGUE
|
7.3%
3/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
General disorders
IMPAIRED HEALING
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
General disorders
MALAISE
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
General disorders
MEDICAL DEVICE COMPLICATION
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
General disorders
OEDEMA
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
General disorders
OEDEMA PERIPHERAL
|
22.0%
9/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
General disorders
PYREXIA
|
17.1%
7/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Hepatobiliary disorders
CHOLESTASIS
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Hepatobiliary disorders
HEPATOCELLULAR INJURY
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
ASYMPTOMATIC BACTERIURIA
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
BACTERIAL INFECTION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
BACTERIURIA
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
BK VIRUS INFECTION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
BRONCHITIS
|
12.2%
5/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
BRONCHITIS VIRAL
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
CATHETER SITE INFECTION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
CYSTITIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
DENTAL GANGRENE
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
DEVICE RELATED SEPSIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
EAR INFECTION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
ERYSIPELAS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
FOLLICULITIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
GASTROENTERITIS
|
7.3%
3/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
GENITAL INFECTION FUNGAL
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
HERPES ZOSTER
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
INFECTION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
INFLUENZA
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
LARYNGITIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
LUNG INFECTION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
LYMPHANGITIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
NASOPHARYNGITIS
|
19.5%
8/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
ONYCHOMYCOSIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
ORAL FUNGAL INFECTION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
ORAL HERPES
|
7.3%
3/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
OTITIS MEDIA
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
PHARYNGITIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
PULMONARY SEPSIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
PYELONEPHRITIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
RHINITIS
|
7.3%
3/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
SINUSITIS
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
TINEA PEDIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
URINARY TRACT INFECTION
|
17.1%
7/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
VAGINITIS BACTERIAL
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Infections and infestations
VIRAL INFECTION
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Injury, poisoning and procedural complications
ARTERIOVENOUS FISTULA SITE COMPLICATION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Injury, poisoning and procedural complications
CONTUSION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Injury, poisoning and procedural complications
PROCEDURAL COMPLICATION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Injury, poisoning and procedural complications
SHUNT MALFUNCTION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Injury, poisoning and procedural complications
SKELETAL INJURY
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Injury, poisoning and procedural complications
WOUND
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Investigations
BLOOD PRESSURE INCREASED
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Investigations
CARDIAC MURMUR
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Investigations
EOSINOPHIL COUNT INCREASED
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Investigations
FREE HAEMOGLOBIN PRESENT
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Investigations
PLATELET COUNT DECREASED
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Investigations
URINE PROTEIN/CREATININE RATIO INCREASED
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Investigations
WEIGHT DECREASED
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Metabolism and nutrition disorders
ACIDOSIS
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Metabolism and nutrition disorders
ELECTROLYTE IMBALANCE
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Metabolism and nutrition disorders
HYPERCREATININAEMIA
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
9.8%
4/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Metabolism and nutrition disorders
HYPERPHOSPHATAEMIA
|
12.2%
5/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Metabolism and nutrition disorders
HYPERVOLAEMIA
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
7.3%
3/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
9.8%
4/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
9.8%
4/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Metabolism and nutrition disorders
IRON DEFICIENCY
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Metabolism and nutrition disorders
OVERWEIGHT
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
9.8%
4/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
19.5%
8/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
7.3%
3/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Musculoskeletal and connective tissue disorders
CHONDROCALCINOSIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Musculoskeletal and connective tissue disorders
HAEMARTHROSIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Musculoskeletal and connective tissue disorders
JOINT EFFUSION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Musculoskeletal and connective tissue disorders
JOINT STIFFNESS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
9.8%
4/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Musculoskeletal and connective tissue disorders
OSTEOPENIA
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Musculoskeletal and connective tissue disorders
RHABDOMYOLYSIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PARATHYROID TUMOUR BENIGN
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Nervous system disorders
AMNESIA
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Nervous system disorders
DIZZINESS
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Nervous system disorders
HEADACHE
|
36.6%
15/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Nervous system disorders
MIGRAINE
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Nervous system disorders
PARAESTHESIA
|
7.3%
3/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Nervous system disorders
POLYNEUROPATHY
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Nervous system disorders
PRESYNCOPE
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Nervous system disorders
SCIATICA
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Nervous system disorders
SYNCOPE
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Nervous system disorders
TREMOR
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Psychiatric disorders
AGITATION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Psychiatric disorders
ANXIETY
|
9.8%
4/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Psychiatric disorders
DEPRESSED MOOD
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Psychiatric disorders
DEPRESSION
|
7.3%
3/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Psychiatric disorders
INSOMNIA
|
12.2%
5/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Psychiatric disorders
NIGHTMARE
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Renal and urinary disorders
ANURIA
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Renal and urinary disorders
DYSURIA
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Renal and urinary disorders
HAEMATURIA
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Renal and urinary disorders
PROTEINURIA
|
12.2%
5/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Renal and urinary disorders
RENAL FAILURE CHRONIC
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
14.6%
6/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Renal and urinary disorders
RENAL VESSEL DISORDER
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Renal and urinary disorders
TUBULOINTERSTITIAL NEPHRITIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Renal and urinary disorders
URINE ABNORMALITY
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Renal and urinary disorders
VESICOURETERIC REFLUX
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Reproductive system and breast disorders
AMENORRHOEA
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Reproductive system and breast disorders
ATROPHIC VULVOVAGINITIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Reproductive system and breast disorders
BREAST CYST
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Reproductive system and breast disorders
DYSMENORRHOEA
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Reproductive system and breast disorders
ENDOMETRIOSIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Reproductive system and breast disorders
HAEMATOSPERMIA
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Reproductive system and breast disorders
METRORRHAGIA
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
17.1%
7/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
12.2%
5/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Respiratory, thoracic and mediastinal disorders
NASAL SEPTUM DEVIATION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
7.3%
3/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY CONGESTION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Respiratory, thoracic and mediastinal disorders
SNORING
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
12.2%
5/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Skin and subcutaneous tissue disorders
INTERTRIGO
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Skin and subcutaneous tissue disorders
PETECHIAE
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Skin and subcutaneous tissue disorders
PHOTOSENSITIVITY REACTION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
9.8%
4/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Skin and subcutaneous tissue disorders
PURPURA
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Skin and subcutaneous tissue disorders
RASH
|
9.8%
4/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Skin and subcutaneous tissue disorders
SKIN DISCOLOURATION
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
4.9%
2/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Vascular disorders
HAEMATOMA
|
7.3%
3/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Vascular disorders
HOT FLUSH
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Vascular disorders
HYPERTENSION
|
12.2%
5/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Vascular disorders
HYPOTENSION
|
17.1%
7/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Vascular disorders
STEAL SYNDROME
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Vascular disorders
THROMBOPHLEBITIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
|
|
Vascular disorders
VENOUS THROMBOSIS
|
2.4%
1/41 • Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Participation in this multicenter study involved a commitment to publish the data from the study in a cooperative publication prior to release of study results on an individual basis.
- Publication restrictions are in place
Restriction type: OTHER