Trial Outcomes & Findings for Open Label Controlled Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Resistant aHUS (NCT NCT00844844)

NCT ID: NCT00844844

Last Updated: 2015-07-23

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: From Baseline to 26 weeks
• Results posted on: 2015-07-23

Participant Flow

C08-002A/B combined 2 studies: one for adults (C08-002A, N=16) and one for adolescents (C08-002B, N=1) Please refer to NCT00844545 for combined studies with enrollment number corresponding to each individual study

Patients had to exhibit a decrease in platelet count despite at least 4 Plasma Therapy (PT) treatments in the 1 week immediately prior to screening. Patients who met the eligibility criteria during screening 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	17
Screening Period COMPLETED	17
Screening Period NOT COMPLETED	0
Treatment Period (26 Weeks) STARTED	17
Treatment Period (26 Weeks) COMPLETED	15
Treatment Period (26 Weeks) NOT COMPLETED	2
Extension Treatment Period STARTED	13
Extension Treatment Period COMPLETED	11
Extension Treatment Period NOT COMPLETED	2
Post Treatment Period STARTED	6
Post Treatment Period COMPLETED	5
Post Treatment Period 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.
Treatment Period (26 Weeks) Adverse Event	1
Treatment Period (26 Weeks) Protocol Violation	1
Extension Treatment Period Adverse Event	2
Post Treatment Period Withdrawal by Subject	1

Baseline Characteristics

Open Label Controlled Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Resistant aHUS

Baseline characteristics by cohort

Measure	Eculizumab n=17 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	31.8 Years STANDARD_DEVIATION 13.32 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to 26 weeks

Population: 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 visit 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=17 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.

Platelet Count Change From Baseline to 26 Weeks

65.18 10^9 cells/L Interval 37.01 to 93.36

PRIMARY outcome

Timeframe: Through 26 weeks

Population: The Tabulations of the proportion of patients who achieved platelet count normalization through 26 weeks were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.

The primary objective of the study (per protocol) was to assess the effect of eculizumab to reduce TMA as measured by platelet count change from baseline (BL) during the Treatment Period (26 weeks) in patients with plasma therapy (PT)-resistant aHUS (protocol defined), including assessment of the proportion of patients who achieved Platelet Count Normalization from baseline through 26 weeks. 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=17 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.

Percentage of Patients With Platelet Count Normalization

82 Percentage of Participants Interval 57.0 to 96.0

PRIMARY outcome

Timeframe: Through 26 weeks

Population: Tabulations of the proportion of patients who achieved a hematologic normalization through 26 weeks were performed for the ITT population. Exact 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=17 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.

Percentage of Patients With Hematologic Normalization

76 Percentage of Participants Interval 50.0 to 93.0

SECONDARY outcome

Timeframe: Through 26 weeks

Population: 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 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=17 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.

Percentage of Patients With Complete TMA Response

65 Percentage of Participants Interval 38.0 to 86.0

SECONDARY outcome

Timeframe: Through 26 weeks

Population: 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=17 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.

TMA Intervention Rate

0.04 # events/patient/day Standard Deviation 0.10

SECONDARY outcome

Timeframe: From Baseline to 156 Weeks

Population: 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=17 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.

Platelet Count Change From Baseline to 156 Weeks

111.62 10^9 cells/L Interval 98.12 to 125.13

SECONDARY outcome

Timeframe: Through End of Study, Median Exposure 100.29 Weeks

Population: The Tabulations of the proportion of patients who achieved platelet count normalization through end of the study were performed for the ITT population. Exact binomial 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=17 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.

Percentage of Patients With Platelet Count Normalization

88 Percentage of Participants Interval 64.0 to 99.0

SECONDARY outcome

Timeframe: Through End of Study, Median Exposure 100.29 Weeks

Population: Tabulations of the proportion of patients who achieved a hematologic normalization through end of study were performed for the ITT population. Exact 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=17 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.

Percentage of Patients With Hematologic Normalization

88 Percentage of Participants Interval 64.0 to 99.0

SECONDARY outcome

Timeframe: Through End of Study, Median Exposure 100.29 Weeks

Population: 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 confidence intervals were produced.

The proportion of patients who achieved a Complete TMA Response from baseline through end of the study 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=17 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.

Percentage of Patients With Complete TMA Response

76 Percentage of Participants Interval 50.0 to 93.0

SECONDARY outcome

Timeframe: Through End of Study, Median Exposure 100.29 Weeks

Population: 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 the study) for PE/PI and (from the fifteenth day following the first eculizumab dose through end of the study) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.

Outcome measures

Measure

Eculizumab n=17 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.

TMA Intervention Rate

0.04 # events/patient/day Standard Deviation 0.11

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=17 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.
Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration max concentration during induction period	145.16 micrograms/mil Standard Deviation 26.56
Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration min concentration during induction period	93.66 micrograms/mil Standard Deviation 22.10
Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration max concentration during maintenace	345.14 micrograms/mil Standard Deviation 89.74
Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration Min concentration during maintenance	151.80 micrograms/mil Standard Deviation 68.16

Adverse Events

Eculizumab

Serious events: 17 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Eculizumab n=17 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 Anaemia	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Haemolytic anaemia	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Haemolytic uraemic syndrome	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Pancytopenia	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Bradycardia	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Pericardial effusion	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Gastritis	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Ileus	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Oesophagitis	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Pancreatitis acute	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Asymptomatic bacteriuria	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 sepsis	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Varicella	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Respiratory fume inhalation disorder	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Systemic lupus erythematosus	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Convulsion	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Posterior reversible encephalopathy syndrome	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Alcohol withdrawal syndrome	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	17.6% 3/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Adenomyosis	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Metrorrhagia	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Accelerated hypertension	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Embolism venous	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	17.6% 3/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Malignant hypertension	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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=17 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 Anaemia	35.3% 6/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	17.6% 3/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Bradycardia	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Pericardial effusion	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Cerumen impaction	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Cushingoid	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Hyperparathyroidism secondary	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Hypothalamo-pituitary disorder	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Cataract	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Conjunctival haemorrhage	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Conjunctival hyperaemia	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 pain	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Photophobia	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Dental caries	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	47.1% 8/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Food poisoning	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Gastritis	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 pain	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Glossodynia	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	29.4% 5/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Oral pain	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Rectal haemorrhage	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Toothache	17.6% 3/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	47.1% 8/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	17.6% 3/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Cyst	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Face oedema	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	17.6% 3/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Influenza like illness	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	29.4% 5/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	17.6% 3/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	17.6% 3/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Tenderness	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Thirst	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Cholestasis	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Abscess	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	23.5% 4/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Campylobacter infection	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Conjunctivitis infective	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Cystitis	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Ear infection	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	17.6% 3/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Genital herpes	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Haemophilus infection	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Impetigo	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Lower respiratory tract infection	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	17.6% 3/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Onychomycosis	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Papilloma viral infection	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Pharyngitis	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Pharyngitis streptococcal	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Rhinitis	17.6% 3/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Staphylococcal infection	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Tonsillitis	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Tooth abscess	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Tooth infection	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Tracheobronchitis	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	23.5% 4/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	35.3% 6/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 bacterial	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 aneurysm	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Eye injury	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Incision site oedema	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Laceration	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Muscle rupture	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Vascular graft complication	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Antibiotic resistant Staphylococcus test positive	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Carbon dioxide abnormal	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Haematocrit decreased	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Haemoglobin decreased	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 decreased	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Vitamin D decreased	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Dyslipidaemia	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 retention	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Hyperlipidaemia	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Hyperphosphataemia	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Hypocalcaemia	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	17.6% 3/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Hypomagnesaemia	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Iron deficiency	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Obesity	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	17.6% 3/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Intervertebral disc degeneration	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Osteopenia	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Systemic lupus erythematosus	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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) Uterine leiomyoma	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Ageusia	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	17.6% 3/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	41.2% 7/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Lethargy	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Loss of consciousness	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Migraine	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Peripheral sensory neuropathy	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Presyncope	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Sinus headache	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Tremor	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Alcoholism	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Dysthymic disorder	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	23.5% 4/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Nervousness	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Sleep disorder	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Nephropathy toxic	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 pain	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Adenomyosis	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 calcifications	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Cervical dysplasia	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Metrorrhagia	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Uterine malposition	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Vulvovaginal discomfort	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	23.5% 4/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 exertional	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Emphysema	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 septum deviation	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Pleural effusion	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Sinus congestion	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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-airway cough syndrome	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 contact	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Dry skin	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Increased tendency to bruise	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Pruritus	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 depigmentation	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 irritation	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 lesion	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Urticaria	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Tooth extraction	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	41.2% 7/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	11.8% 2/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Poor venous access	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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 Thrombophlebitis superficial	5.9% 1/17 • Through end of study; Exposure to eculizumab in this study extended for a median of 100 weeks and ranged from two weeks to 186 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

Alexion Pharmaceuticals Inc.

Alexion Pharmaceuticals, Inc.

Email: clinicaltrials@alxn.com

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