Trial Outcomes & Findings for Study of the Clinical Effectiveness of a Human Monoclonal Antibody to C. Difficile Toxin A and Toxin B in Patients With Clostridium Difficile Associated Disease (NCT NCT00350298)

Last Updated: 2021-02-09

Results Overview

Determine if the addition of C. difficile toxin A and toxin B human monoclonal anti-toxin antibodies to standard of care treatment reduces the number of subjects with recurrent CDAD compared to standard of care and placebo. Standard of care treatment is defined as receipt of either metronidazole by mouth or parenterally or receipt of vancomycin by mouth with a standard duration of treatment defined as 10 - 14 days (+ 2 days)). Recurrence of CDAD is defined as the development of a new episode of C. difficile disease associated with a positive C. difficile stool toxin(s) test after the resolution of prior episode and after discontinuation of SOC treatment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

200 participants

Primary outcome timeframe

Day 0 to Day 84

Results posted on

2021-02-09

Participant Flow

Inpatients and outpatients diagnosed with laboratory confirmed C. difficile disease whose physicians had opted to treat with standard of care (SOC) antibiotics, metronidazole by mouth (po)/ Intravenous (IV) or vancomycin po. A patient is considered eligible to participate in the study if a stool sample collected within 14 days of enrollment was positive by either the hospital/reference microbiology laboratory test or the rapid diagnostic test.

Prior to enrollment, patients had to meet the study definition of disease which allowed the inclusion of patients with moderate to severe diarrhea or colitis with or without accompanying systemic symptoms/signs (such as fever, nausea, anorexia, leukocytosis, abdominal pain, cramping or discomfort) whose disease was likely to continue for at least a few days after study enrollment.

Participant milestones

Participant milestones
Measure	GS-CDA1/MDX-1388 Biological: GS-CDA1/MDX-1388 One Intravenous dose	Placebo Biological: normal saline (0.9% sodium chloride) One Intravenous dose
Overall Study STARTED	101	99
Overall Study COMPLETED	92	86
Overall Study NOT COMPLETED	9	13

Reasons for withdrawal

Reasons for withdrawal
Measure	GS-CDA1/MDX-1388 Biological: GS-CDA1/MDX-1388 One Intravenous dose	Placebo Biological: normal saline (0.9% sodium chloride) One Intravenous dose
Overall Study Death	7	8
Overall Study Lost to Follow-up	1	2
Overall Study Withdrawal by Subject	1	3

Baseline Characteristics

Study of the Clinical Effectiveness of a Human Monoclonal Antibody to C. Difficile Toxin A and Toxin B in Patients With Clostridium Difficile Associated Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GS-CDA1/MDX-1388 n=101 Participants Biological: GS-CDA1/MDX-1388 One Intravenous dose	Placebo n=99 Participants Biological: normal saline (0.9% sodium chloride) One Intravenous dose	Total n=200 Participants Total of all reporting groups
Age, Continuous	63 years STANDARD_DEVIATION 16.24 • n=5 Participants	64 years STANDARD_DEVIATION 15.02 • n=7 Participants	64 years STANDARD_DEVIATION 15.62 • n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	71 Participants n=7 Participants	132 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	28 Participants n=7 Participants	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	97 Participants n=5 Participants	93 Participants n=7 Participants	190 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	91 Participants n=5 Participants	84 Participants n=7 Participants	175 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
A modified Horn's index for severity of underlying disease	2 Scores on a severity scale n=5 Participants	2 Scores on a severity scale n=7 Participants	2 Scores on a severity scale n=5 Participants

PRIMARY outcome

Timeframe: Day 0 to Day 84

Population: 200 subjects who met the eligibility criteria and signed the informed consent and received standard of care treatment randomized 1:1 treatment allocation to receive study treatment: 101 subjects in the GS-CDA1/MDX-1388 (Monoclonal antibody (Mab)) treatment group and 99 subjects in the placebo treatment group

Outcome measures

Outcome measures
Measure	GS-CDA1/MDX-1388 n=101 Participants Biological: GS-CDA1/MDX-1388 One Intravenous dose	Placebo n=99 Participants Biological: normal saline (0.9% sodium chloride) One Intravenous dose
Number of Participants With Recurrence of Clostridium Difficile Associated Disease (CDAD)	7 Participants	25 Participants

SECONDARY outcome

Timeframe: Day 0 to Day 84

Safety and tolerability of a C. difficile toxin A human monoclonal antibody combined with a human monoclonal antibody to C. difficile toxin B in patients receiving standard of care treatment for C. difficile associated disease (CDAD) compared to those patients receiving standard of care and placebo reporting system organ class (SOC) MedDRA V.9.0

Outcome measures

Outcome measures
Measure	GS-CDA1/MDX-1388 n=101 Participants Biological: GS-CDA1/MDX-1388 One Intravenous dose	Placebo n=99 Participants Biological: normal saline (0.9% sodium chloride) One Intravenous dose
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported Blood And Lymphatic System Disorders	30 Adverse Events	41 Adverse Events
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported Cardiac Disorders	13 Adverse Events	20 Adverse Events
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported Ear and Labyrinth	3 Adverse Events	3 Adverse Events
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported Endocrine Disorders	0 Adverse Events	1 Adverse Events
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported Eye Disorder	7 Adverse Events	7 Adverse Events
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported Gastrointestinal Disorders	312 Adverse Events	395 Adverse Events
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported General Disorders	91 Adverse Events	128 Adverse Events
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported Hepatobiliary Disorders	1 Adverse Events	1 Adverse Events
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported Immune Disorders	1 Adverse Events	0 Adverse Events
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported Infections And Infestations	68 Adverse Events	83 Adverse Events
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported Injury, Poisoning And Procedural Complications	9 Adverse Events	19 Adverse Events
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported Investigations	18 Adverse Events	30 Adverse Events
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported Metabolism And Nutrition Disorders	55 Adverse Events	128 Adverse Events
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported Musculoskeletal And Connective Tissue Disorders	37 Adverse Events	46 Adverse Events
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)	3 Adverse Events	1 Adverse Events
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported Nervous System Disorders	61 Adverse Events	79 Adverse Events
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported Psychiatric Disorders	11 Adverse Events	36 Adverse Events
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported Renal And Urinary Disorders	9 Adverse Events	9 Adverse Events
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported Reproductive System And Breast Disorders	6 Adverse Events	1 Adverse Events
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported Respiratory, Thoracic And Mediastinal Disorders	36 Adverse Events	61 Adverse Events
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported Skin And Subcutaneous Tissue Disorders	27 Adverse Events	17 Adverse Events
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported Surgical And Medical Procedures	4 Adverse Events	3 Adverse Events
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported Vascular Disorders	9 Adverse Events	19 Adverse Events

SECONDARY outcome

Timeframe: Day 0 to Day 84

Population: 200 subjects who met the eligibility criteria and signed the informed consent and received standard of care treatment were randomized 1:1 treatment allocation to receive study treatment: 101 subjects in the GS-CDA1/MDX-1388 (Monoclonal antibody (Mab)) treatment group and 99 subjects in the placebo treatment group

Determine if the addition of a C. difficile toxin A human monoclonal antibody combined with C. difficile toxin B human monoclonal antibody to standard of care treatment reduces the time to resolution of diarrhea in patients with CDAD compared to those patients receiving standard of care and placebo. Resolution of CDAD is defined as the cessation of diarrhea for at least two consecutive days.

Outcome measures

Outcome measures
Measure	GS-CDA1/MDX-1388 n=101 Participants Biological: GS-CDA1/MDX-1388 One Intravenous dose	Placebo n=99 Participants Biological: normal saline (0.9% sodium chloride) One Intravenous dose
Time to Resolution of Initial CDAD Episode	3 Days Interval 0.0 to 84.0	3 Days Interval 0.0 to 58.0

SECONDARY outcome

Timeframe: Day 0 to Day 84

Determine if the addition of a C. difficile toxin A human monoclonal antibody combined with C. difficile toxin B human monoclonal antibody to standard of care treatment reduces the number of patients who experience standard of care treatment failure compared to those patients receiving standard of care and placebo. Standard of care treatment failure is defined as (i) recurrence of diarrhea (after it had initially resolved) while on SOC treatment during the first 14 days, or (ii) change in SOC treatment (i.e., antibiotics given), or (iii) diarrhea episode lasting ≥14 days while on SOC treatment.

Outcome measures

Outcome measures
Measure	GS-CDA1/MDX-1388 n=101 Participants Biological: GS-CDA1/MDX-1388 One Intravenous dose	Placebo n=99 Participants Biological: normal saline (0.9% sodium chloride) One Intravenous dose
Number of Patients With Standard of Care Treatment Failure	21 Participants	24 Participants

SECONDARY outcome

Timeframe: Day 0 to Day 84

Population: 200 subjects who met the eligibility criteria and signed the informed consent randomized to receive study treatment: 101 in the GS-CDA1 and MDX-1388 (Monoclonal antibody (Mab)) treatment group and 99 in the placebo treatment group.

Determine if the addition of a C. difficile toxin A human monoclonal antibody combined with C. difficile toxin B human monoclonal antibody to standard of care treatment reduces the number of patients with severe C. difficile disease compared to those patients receiving standard of care and placebo. Severe initial disease is defined as ≥ 5 unformed stools/day for 2 consecutive days from day 1 to the end of the initial episode of diarrhea and discontinuation of SOC.

Outcome measures

Outcome measures
Measure	GS-CDA1/MDX-1388 n=101 Participants Biological: GS-CDA1/MDX-1388 One Intravenous dose	Placebo n=99 Participants Biological: normal saline (0.9% sodium chloride) One Intravenous dose
Number of Patients With Severe Initial C. Difficile Disease	29 Participants	37 Participants

SECONDARY outcome

Timeframe: Day 0 to Day 84

Antibody concentrations to Toxin A and to Toxin B in those patients receiving C. difficile toxin A human monoclonal antibody combined with C. difficile toxin B human monoclonal antibody and standard of care treatment to those patients receiving standard of care and placebo

Outcome measures

Outcome measures
Measure	GS-CDA1/MDX-1388 n=101 Participants Biological: GS-CDA1/MDX-1388 One Intravenous dose	Placebo n=99 Participants Biological: normal saline (0.9% sodium chloride) One Intravenous dose
Antibody Concentrations to Toxin A and to Toxin B Between Treatment Groups GS-CDA1 (Toxin A)	115197.1 AUC0-∞ (hours x μg/ml) Standard Deviation 37546.90	NA AUC0-∞ (hours x μg/ml) Standard Deviation NA The majority of subjects in the placebo group had low or no detectable endogenous antibodies against either toxin.
Antibody Concentrations to Toxin A and to Toxin B Between Treatment Groups MDX-1388 (Toxin B)	98540.9 AUC0-∞ (hours x μg/ml) Standard Deviation 129413.74	NA AUC0-∞ (hours x μg/ml) Standard Deviation NA The majority of subjects in the placebo group had low or no detectable endogenous antibodies against either toxin.

Adverse Events

GS-CDA1/MDX-1388

Serious events: 18 serious events

Other events: 100 other events

Deaths: 7 deaths

Placebo

Serious events: 28 serious events

Other events: 99 other events

Deaths: 8 deaths

Serious adverse events

Other adverse events

Additional Information

Director of Clinical Affairs

MassBiologics

Phone: 617-474-3000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	GS-CDA1/MDX-1388 n=101 participants at risk Biological: GS-CDA1/MDX-1388 One Intravenous dose	Placebo n=99 participants at risk Biological: normal saline (0.9% sodium chloride) One Intravenous dose
Blood and lymphatic system disorders ANAEMIA	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	0.00% 0/99 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Blood and lymphatic system disorders HAEMOLYTIC ANAEMIA	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	0.00% 0/99 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Blood and lymphatic system disorders LEUKOCYTOSIS	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	4.0% 4/99 • Number of events 4 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	0.00% 0/99 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Cardiac disorders ANGINA PECTORIS	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	3.0% 3/99 • Number of events 3 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Cardiac disorders CARDIO-RESPIRATORY ARREST	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	2.0% 2/99 • Number of events 2 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Cardiac disorders MYOCARDIAL INFARCTION	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	0.00% 0/99 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Cardiac disorders TACHYCARDIA	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	2.0% 2/99 • Number of events 3 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	2.0% 2/99 • Number of events 2 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Gastrointestinal disorders COLITIS	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Gastrointestinal disorders DIARRHOEA	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	5.1% 5/99 • Number of events 6 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	2.0% 2/99 • Number of events 2 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Gastrointestinal disorders NAUSEA	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Gastrointestinal disorders VOMITING	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	2.0% 2/99 • Number of events 2 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
General disorders ASTHENIA	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
General disorders CHEST PAIN	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
General disorders LOWER EXTREMITY MASS	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	0.00% 0/99 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
General disorders OEDEMA PERIPHERAL	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
General disorders PYREXIA	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	2.0% 2/99 • Number of events 2 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
General disorders SUDDEN DEATH	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	0.00% 0/99 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Hepatobiliary disorders HEPATITIS	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	0.00% 0/99 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Infections and infestations CLOSTRIDIUM DIFFICILE COLITIS	5.0% 5/101 • Number of events 5 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	7.1% 7/99 • Number of events 7 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Infections and infestations INFECTION	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Infections and infestations LOBAR PNEUMONIA	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	2.0% 2/99 • Number of events 2 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Infections and infestations PNEUMOCYSTIS JIROVECI PNEUMONIA	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	0.00% 0/99 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Infections and infestations PNEUMONIA	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	3.0% 3/99 • Number of events 3 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Infections and infestations PNEUMONIA STAPHYLOCOCCAL	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	0.00% 0/99 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Infections and infestations SEPSIS	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	4.0% 4/99 • Number of events 4 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Infections and infestations SEPTIC SHOCK	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Infections and infestations STAPHYLOCOCCAL INFECTION	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Infections and infestations URINARY TRACT INFECTION	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Infections and infestations UROSEPSIS	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Injury, poisoning and procedural complications DIALYSIS DEVICE COMPLICATION	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 2 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Injury, poisoning and procedural complications SPINAL COMPRESSION FRACTURE	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	0.00% 0/99 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Investigations BLOOD CULTURE POSITIVE	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Investigations BLOOD PRESSURE INCREASED	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period

Other adverse events
Measure	GS-CDA1/MDX-1388 n=101 participants at risk Biological: GS-CDA1/MDX-1388 One Intravenous dose	Placebo n=99 participants at risk Biological: normal saline (0.9% sodium chloride) One Intravenous dose
Blood and lymphatic system disorders ANAEMIA	4.0% 4/101 • Number of events 5 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	5.1% 5/99 • Number of events 5 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Blood and lymphatic system disorders COAGULOPATHY	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	2.0% 2/99 • Number of events 2 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Blood and lymphatic system disorders LEUKOCYTOSIS	14.9% 15/101 • Number of events 21 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	18.2% 18/99 • Number of events 27 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Blood and lymphatic system disorders NEUTROPHILIA	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Blood and lymphatic system disorders SPLENOMEGALY	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	0.00% 0/99 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Cardiac disorders ARRHYTHMIA	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	0.00% 0/99 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Cardiac disorders ATRIAL FIBRILLATION	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 2 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 2 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Cardiac disorders CARDIOMYOPATHY	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Cardiac disorders PALPITATIONS	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	2.0% 2/99 • Number of events 2 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Cardiac disorders PERICARDIAL EFFUSION	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	0.00% 0/99 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Cardiac disorders PERICARDIAL HAEMORRHAGE	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	0.00% 0/99 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Cardiac disorders PERICARDITIS	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	0.00% 0/99 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	0.00% 0/99 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Cardiac disorders TACHYCARDIA	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	2.0% 2/99 • Number of events 2 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Ear and labyrinth disorders EAR PAIN	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	0.00% 0/99 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Ear and labyrinth disorders EXTERNAL EAR INFLAMMATION	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Ear and labyrinth disorders TINNITUS	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Ear and labyrinth disorders VERTIGO	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Endocrine disorders HYPOTHYROIDISM	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Eye disorders CONJUNCTIVITIS	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 2 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Eye disorders CONJUNCTIVITIS ALLERGIC	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	0.00% 0/99 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Eye disorders DRY EYE	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 2 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Eye disorders ECTROPION	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	0.00% 0/99 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Eye disorders EYE INFLAMMATION	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Eye disorders KERATITIS	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	0.00% 0/99 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Eye disorders LACRIMATION INCREASED	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	0.00% 0/99 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Eye disorders OCULAR HYPERAEMIA	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Eye disorders VISION BLURRED	0.99% 1/101 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Gastrointestinal disorders ABDOMINAL DISCOMFORT	2.0% 2/101 • Number of events 2 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Gastrointestinal disorders ABDOMINAL DISTENSION	5.0% 5/101 • Number of events 5 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	6.1% 6/99 • Number of events 9 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Gastrointestinal disorders ABDOMINAL PAIN	50.5% 51/101 • Number of events 109 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	45.5% 45/99 • Number of events 122 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Gastrointestinal disorders ABDOMINAL PAIN LOWER	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Gastrointestinal disorders ANAL FISSURE	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Gastrointestinal disorders ASCITES	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 2 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Gastrointestinal disorders COELIAC DISEASE	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	1.0% 1/99 • Number of events 1 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Gastrointestinal disorders CONSTIPATION	2.0% 2/101 • Number of events 2 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	2.0% 2/99 • Number of events 2 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Gastrointestinal disorders DIARRHOEA	39.6% 40/101 • Number of events 69 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	55.6% 55/99 • Number of events 104 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period
Gastrointestinal disorders DIVERTICULUM	0.00% 0/101 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period	2.0% 2/99 • Number of events 2 • Adverse events assessed from Day 0 through Day 84 Adverse events assessed by interim medical history reviews, targeted physical assessments and clinical laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms or required new treatment or change in current therapy. Solicited adverse events included the occurrence of fever, chills, rash, joint pain or swelling, shortness of breath, headache, fatigue, or hives during the infusion and/or in the post-infusion period