Trial Outcomes & Findings for Open Label Controlled Trial of Eculizumab in Adult Patients With Plasma Therapy-sensitive Atypical Hemolytic Uremic Syndrome (aHUS) (NCT NCT00838513)
NCT ID: NCT00838513
Last Updated: 2015-07-23
Results Overview
TMA Event-free status is defined as the absence for at least 12 weeks of \[1\] decrease in platelet count of \> 25% from the Platelet Count Pre-PT Baseline Set Point; \[2\] PT while the patient is receiving eculizumab, and \[3\] new dialysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Through 26 weeks
Results posted on
2015-07-23
Participant Flow
C08-003A/B combined 2 studies: one for adults (C08-003A, N=15) and one for adolescents (C08-003B, N=5) Please refer to NCT00844428 for combined studies with enrollment number corresponding to each individual study
Patients receiving PT for aHUS and observed to receive ≥ 1 PT every two weeks, and no more than 3 PT treatments/week for at least 8 weeks before the first dose of eculizumab. Patients who met the eligibility criteria during the Observation Period were enrolled into the Treatment Period which commenced with the first eculizumab dose.
Participant milestones
| Measure |
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
|
23
|
|
Screening Period
COMPLETED
|
20
|
|
Screening Period
NOT COMPLETED
|
3
|
|
Observation Period (8 Weeks)
STARTED
|
20
|
|
Observation Period (8 Weeks)
COMPLETED
|
20
|
|
Observation Period (8 Weeks)
NOT COMPLETED
|
0
|
|
Treatment Period (26 Weeks)
STARTED
|
20
|
|
Treatment Period (26 Weeks)
COMPLETED
|
20
|
|
Treatment Period (26 Weeks)
NOT COMPLETED
|
0
|
|
Extension Treatment Period
STARTED
|
19
|
|
Extension Treatment Period
COMPLETED
|
18
|
|
Extension Treatment Period
NOT COMPLETED
|
1
|
|
Post Treatment Period (Patients Who Disc
STARTED
|
5
|
|
Post Treatment Period (Patients Who Disc
COMPLETED
|
4
|
|
Post Treatment Period (Patients Who Disc
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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
|
|
Extension Treatment Period
Death
|
1
|
|
Post Treatment Period (Patients Who Disc
Death
|
1
|
Baseline Characteristics
Open Label Controlled Trial of Eculizumab in Adult Patients With Plasma Therapy-sensitive Atypical Hemolytic Uremic Syndrome (aHUS)
Baseline characteristics by cohort
| Measure |
Eculizumab
n=20 Participants
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
|
32.3 Years
STANDARD_DEVIATION 14.92 • n=99 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Through 26 weeksPopulation: The tabulations of the proportions of patients who achieved a TMA Event-Free status through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.
TMA Event-free status is defined as the absence for at least 12 weeks of \[1\] decrease in platelet count of \> 25% from the Platelet Count Pre-PT Baseline Set Point; \[2\] PT while the patient is receiving eculizumab, and \[3\] new dialysis.
Outcome measures
| Measure |
Eculizumab
n=20 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 TMA Event-free Status
|
80 Percentage of Participants
Interval 56.0 to 94.0
|
PRIMARY outcome
Timeframe: Through 26 weeksPopulation: Tabulations of the proportion of patients who achieved a hematologic normalization through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.
Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.
Outcome measures
| Measure |
Eculizumab
n=20 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 Hematologic Normalization
|
90 Percentage of Participants
Interval 68.0 to 99.0
|
PRIMARY outcome
Timeframe: Through 26 weeksPopulation: Tabulations of the proportion of patients who achieved a complete TMA response from baseline through 26 weeks were performed. For this endpoint, for any relevant proportions, exact binomial 95% confidence intervals were produced.
The proportion of patients who achieved a Complete TMA Response from baseline through 26 weeks of treatment with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as (≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.
Outcome measures
| Measure |
Eculizumab
n=20 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
|
25 Percentage of Participants
Interval 9.0 to 49.0
|
SECONDARY outcome
Timeframe: Through 26 weeksPopulation: A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.
TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through 26 weeks) for PE/PI and (from the fifteenth day following the first eculizumab dose through 26 weeks) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.
Outcome measures
| Measure |
Eculizumab
n=20 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.
|
|---|---|
|
TMA Intervention Rate
|
0 #events/patient/day
Standard Deviation 0
|
SECONDARY outcome
Timeframe: From Baseline to 26 WeeksPopulation: Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.
Outcome measures
| Measure |
Eculizumab
n=20 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
|
6.75 10^9 cells/L
Interval -15.73 to 29.23
|
SECONDARY outcome
Timeframe: Through 26 WeeksPopulation: The tabulations of the proportion of patients who achieved platelet count normalization through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.
Platelet count normalization was defined as the platelet count observed to be ≥150 x 10\^9/L on at least two consecutive measurements which span a period of at least four weeks
Outcome measures
| Measure |
Eculizumab
n=20 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
|
90 Percentage of Participants
Interval 68.0 to 99.0
|
SECONDARY outcome
Timeframe: Through End of Study, Median Exposure 156 WeeksPopulation: The tabulations of the proportions of patients who achieved a TMA Event-Free status through 26 weeksend of study were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.
TMA Event-free status is defined as the absence for at least 12 weeks of \[1\] decrease in platelet count of \> 25% from the Platelet Count Pre-PT Baseline Set Point; \[2\] PT while the patient is receiving eculizumab, and \[3\] new dialysis.
Outcome measures
| Measure |
Eculizumab
n=20 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 TMA Event-free Status
|
95 Percentage of Participants
Interval 75.0 to 100.0
|
SECONDARY outcome
Timeframe: Through End of Study, Median Exposure 156 WeeksPopulation: Tabulations of the proportion of patients who achieved a hematologic normalization through end of study were performed for the ITT population. Exact 95% binomial confidence intervals were produced for the analysis.
Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.
Outcome measures
| Measure |
Eculizumab
n=20 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 Hematologic Normalization
|
90 Percentage of Participants
Interval 68.0 to 99.0
|
SECONDARY outcome
Timeframe: Through End of Study, Median Exposure 156 WeeksPopulation: Tabulations of the proportion of patients who achieved a complete TMA response from baseline through end of study were performed. For this endpoint, for any relevant proportions, exact binomial 95% confidence intervals were produced.
The proportion of patients who achieved a Complete TMA Response from baseline through end of study with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as (≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.
Outcome measures
| Measure |
Eculizumab
n=20 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
|
55 Percentage of Participants
Interval 32.0 to 77.0
|
SECONDARY outcome
Timeframe: Through End of Study, Median Exposure 156 WeeksPopulation: A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.
TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through end of study) for PE/PI and (from the fifteenth day following the first eculizumab dose through end of study) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.
Outcome measures
| Measure |
Eculizumab
n=20 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.
|
|---|---|
|
TMA Intervention Rate
|
0.00 #events/patient/day
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: From Baseline to 156 WeeksPopulation: Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.
Outcome measures
| Measure |
Eculizumab
n=20 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 156 Weeks
|
-3.68 10^9 cells/L
Interval -25.15 to 17.79
|
SECONDARY outcome
Timeframe: Through End of Study, Median Exposure 156 WeeksPopulation: The tabulations of the proportion of patients who achieved platelet count normalization through end of study were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.
Platelet count normalization was defined as the platelet count observed to be ≥150 x 10\^9/L on at least two consecutive measurements which span a period of at least four weeks Not specified.
Outcome measures
| Measure |
Eculizumab
n=20 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
|
90 Percentage of Participants
Interval 68.0 to 99.0
|
SECONDARY outcome
Timeframe: Induction Phase for 4 weeks followed by Maintenance Phase starting on Week 5 through 26 weeks or longer.Population: PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data.
Outcome measures
| Measure |
Eculizumab
n=20 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.
|
|---|---|
|
Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration
max concentration during induction period
|
161.47 micrograms/mil
Standard Deviation 27.29
|
|
Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration
min concentration during induction period
|
112.43 micrograms/mil
Standard Deviation 16.98
|
|
Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration
max concentration during maintenance
|
427.48 micrograms/mil
Standard Deviation 67.54
|
|
Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration
min concentration during maintenance
|
212.45 micrograms/mil
Standard Deviation 53.75
|
Adverse Events
Eculizumab
Serious events: 13 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Eculizumab
n=20 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Pericardial effusion
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Impaired gastric emptying
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Transplant rejection
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Amyloidosis
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Bacteraemia
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Clostridium difficile colitis
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Enterococcal infection
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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 norovirus
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Hepatitis E
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Localised infection
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Peritonitis
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Post procedural infection
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Q fever
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Hip fracture
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Humerus fracture
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Tendon rupture
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Electrocardiogram T wave inversion
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Osteoarthritis
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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)
Renal cell carcinoma
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.).
|
|
Surgical and medical procedures
Catheter removal
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.).
|
|
Surgical and medical procedures
Limb operation
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Vein disorder
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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 limb
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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=20 participants at risk
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
Abnormal clotting factor
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Anaemia
|
35.0%
7/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Anaemia folate deficiency
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
15.0%
3/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Lymph node pain
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Lymphadenopathy
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Microcytosis
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Splenomegaly
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Hypertensive heart disease
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.).
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Deafness bilateral
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Motion sickness
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
20.0%
4/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Adrenal insufficiency
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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 irritation Conjunctival haemorrhage
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Ocular hyperaemia
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
25.0%
5/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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 lower
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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 rigidity
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Aphthous stomatitis
|
15.0%
3/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Ascites
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
15.0%
3/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Crohn's disease
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
50.0%
10/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Flatulence
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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 bleeding
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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 hyperplasia
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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 ulceration
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Haemorrhoids
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Impaired gastric emptying
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Malaena
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
50.0%
10/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Subileus
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Tooth impacted
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Umbilical hernia
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
50.0%
10/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
20.0%
4/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Extravasation
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
20.0%
4/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Hypothermia
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Infusion site extravasation
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Infusion site swelling
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Injection site haematoma
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Localised oedema
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Medical device pain
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
30.0%
6/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Pain
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Polyp
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
35.0%
7/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Hypersensitivity
|
20.0%
4/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Seasonal allergy
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Ateriovenous fistula site infection
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Bacteraemia
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Cytomegalovirus infection
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Erythrasma
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Escherichia urinary tract infection
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Fungal infection
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Fungal skin infection
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
15.0%
3/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
15.0%
3/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Localised infection
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
60.0%
12/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Post procedural infection
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
15.0%
3/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
40.0%
8/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
15.0%
3/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Vaginal infection
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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 pharyngitis
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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 upper respiratory tract infection
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Vulvovaginal candidiasis
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Ankle fracture
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
20.0%
4/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Corneal abrasion
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Excoriation
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Foreign body
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Head injury
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Hip fracture
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Humerus fracture
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Ligament sprain
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Limb injury
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Scratch
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Wrist fracture
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Basophil count increased
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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 creatine increased
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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 creatinine increased
|
20.0%
4/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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 lactate dehydrogenase increased
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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 parathyroid hormone increased
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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 potassium increased
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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 abnormal
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Electrocardiogram T wave inversion
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Glomerular filtration rate decreased
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Haptoglobin increased
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Low density lipoprotein increased
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Monocyte count increased
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Reticulocyte count increased
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
15.0%
3/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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 cells urine positive
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Alkalosis
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Cachexia
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Fluid overload
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Hyponatraemia
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Malnutrition
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
15.0%
3/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
30.0%
6/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
55.0%
11/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Flank pain
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Groin pain
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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 swelling
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
20.0%
4/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Muscular weakness
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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 chest pain
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Osteoporosis
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
20.0%
4/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Tendon disorder
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Tendonitis
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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)
Angiomyolipoma
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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)
Benign breast neoplasm
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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)
Lipoma
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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)
Melanocytic naevus
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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)
Skin papilloma
|
15.0%
3/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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)
Squamous cell carcinoma
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Cerebral haematoma
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Cerebral microangiopathy
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
15.0%
3/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
55.0%
11/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Myoclonus
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Neuropathy peripheral
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Paresis
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Somnolence
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Affective disorder
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
15.0%
3/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Nephrolithiasis
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Pollakiuria
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
15.0%
3/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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 swelling
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Menorrhagia
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Oedema genital
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Ovarian cyst
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
35.0%
7/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
15.0%
3/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Lung consolidation
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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 congestion
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
20.0%
4/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
15.0%
3/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Upper respiratory tract infection
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Blister
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Ecchymosis
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Heat rash
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Hyperhidrosis
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Pruritis
|
15.0%
3/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Psoriasis
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
20.0%
4/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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 macular
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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 disorder
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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 fissures
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.).
|
|
Surgical and medical procedures
Arteriovenous fistula operation
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.).
|
|
Surgical and medical procedures
Hip arthroplasty
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Arterial haemorrhage
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Arterial occlusive disease
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Haemorrhage
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
45.0%
9/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
20.0%
4/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Orthostatic hypotension
|
10.0%
2/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
Vein disorder
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and 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
|
5.0%
1/20 • Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.).
|
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