Trial Outcomes & Findings for A Study of Clofarabine in Older Patients With Acute Myeloid Leukemia (AML) for Whom Chemotherapy Is Not Suitable (NCT NCT00924443)

NCT ID: NCT00924443

Last Updated: 2015-04-01

Results Overview

ORR rate was defined as the sum of the number of participants in the study population with complete remission (CR), complete remission with incomplete blood count recovery (CRi), or partial remission (PR) divided by the total number of participants in the study population. ORR rate was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment. The ORR was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 69 participants
• Primary outcome timeframe: At month 20
• Results posted on: 2015-04-01

Participant Flow

Participants were entered into the study between 14 Jun 2004 and 14 Nov 2005. Participants were recruited from 14 of a total of 17 registered centres located in the United Kingdom (UK), Ireland and Italy. Relapse and survival data follow-up cut-off was extended to 23 May 2008.

A total of 69 participants were screened and enrolled. A total of 66 participants received study drug and are included in the reported results.

Participant milestones

Measure	Clofarabine Clofarabine 30 mg/m\^2/day intravenously over 1 hour for 5 days every 29 to 43 days
Overall Study STARTED	69
Overall Study Full Analysis Set (Received Study Drug)	66
Overall Study COMPLETED	66
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Clofarabine Clofarabine 30 mg/m\^2/day intravenously over 1 hour for 5 days every 29 to 43 days
Overall Study Physician Decision	2
Overall Study Protocol Violation	1

Baseline Characteristics

A Study of Clofarabine in Older Patients With Acute Myeloid Leukemia (AML) for Whom Chemotherapy Is Not Suitable

Baseline characteristics by cohort

Measure	Clofarabine n=66 Participants Clofarabine 30 mg/m\^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m\^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
Age, Continuous	71.5 years STANDARD_DEVIATION 4.65 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	66 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Ireland	3 participants n=5 Participants
Region of Enrollment Italy	8 participants n=5 Participants
Region of Enrollment United Kingdom	55 participants n=5 Participants
Cytogenetics (1998) Favourable	0 participants n=5 Participants
Cytogenetics (1998) Intermediate	43 participants n=5 Participants
Cytogenetics (1998) Adverse	19 participants n=5 Participants
Cytogenetics (1998) Missing/Unknown	4 participants n=5 Participants
Cytogenetics (2001) Favourable	0 participants n=5 Participants
Cytogenetics (2001) Intermediate	48 participants n=5 Participants
Cytogenetics (2001) Adverse	14 participants n=5 Participants
Cytogenetics (2001) Missing/Unknown	4 participants n=5 Participants
Type of Acute Myeloid Leukemia (AML) De Novo	48 participants n=5 Participants
Type of Acute Myeloid Leukemia (AML) Secondary	16 participants n=5 Participants
Type of Acute Myeloid Leukemia (AML) Missing/Unknown	2 participants n=5 Participants
White Blood Cell Count (10^9/L) <25	57 participants n=5 Participants
White Blood Cell Count (10^9/L) 25-99.9	6 participants n=5 Participants
White Blood Cell Count (10^9/L) >=100	3 participants n=5 Participants
Glomerular Filtration Rate (mL/min/1.73m^2) <=50	15 participants n=5 Participants
Glomerular Filtration Rate (mL/min/1.73m^2) >50	51 participants n=5 Participants
Number of Co-morbidities 0	17 participants n=5 Participants
Number of Co-morbidities 1	23 participants n=5 Participants
Number of Co-morbidities >1	26 participants n=5 Participants
Karnofsky Performance Status 100%	8 participants n=5 Participants
Karnofsky Performance Status 90%	13 participants n=5 Participants
Karnofsky Performance Status 80%	24 participants n=5 Participants
Karnofsky Performance Status 70%	9 participants n=5 Participants
Karnofsky Performance Status 60%	2 participants n=5 Participants
Karnofsky Performance Status 50%	5 participants n=5 Participants
Karnofsky Performance Status 20%	2 participants n=5 Participants
Karnofsky Performance Status Missing	3 participants n=5 Participants

PRIMARY outcome

Timeframe: At month 20

Population: The efficacy analysis was performed on the primary analysis population, the Full Analysis Set population, which consisted of all participants with a diagnosis of AML confirmed by the Investigator who received at least one dose (partial or complete) of clofarabine.

ORR rate was defined as the sum of the number of participants in the study population with complete remission (CR), complete remission with incomplete blood count recovery (CRi), or partial remission (PR) divided by the total number of participants in the study population.

ORR rate was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment. The ORR was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment.

Outcome measures

Measure	Clofarabine n=66 Participants Clofarabine 30 mg/m\^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m\^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
Overall Response Rate (ORR)	48 percentage of participants Interval 36.0 to 61.0

SECONDARY outcome

Timeframe: At month 20

Population: The efficacy analyses were performed on the primary analysis population, the Full Analysis Set population, which consisted of all participants with a diagnosis of AML confirmed by the Investigator who received at least one dose (partial or complete) of clofarabine.

Response was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment.

Response was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment.

Outcome measures

Measure	Clofarabine n=66 Participants Clofarabine 30 mg/m\^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m\^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial) Complete response	21 percent of participants Interval 12.0 to 33.0
Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial) Complete with incomplete blood count recovery	23 percent of participants Interval 13.0 to 35.0
Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial) Partial response	5 percent of participants Interval 1.0 to 13.0

SECONDARY outcome

Timeframe: From 20 months up to 48 months

Population: The analysis were performed on the primary analysis population, the Full Analysis Set population. Defined as the median duration of overall response (CR+CRi+PR) in participants who achieved CR, CRi or PR only

Duration was calculated by Kaplan-Meier estimates

Outcome measures

Measure	Clofarabine n=32 Participants Clofarabine 30 mg/m\^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m\^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
Duration of Overall Response	62 days Interval 42.0 to 153.0

SECONDARY outcome

Timeframe: From 20 months up to 48 months

Population: The efficacy analyses were performed on the primary analysis population, the Full Analysis Set population, which consisted of all participants with a diagnosis of AML confirmed by the Investigator who received at least one dose (partial or complete) of clofarabine.

Calculated by Kaplan-Meier estimates

Outcome measures

Measure	Clofarabine n=66 Participants Clofarabine 30 mg/m\^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m\^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
Overall Survival	173 days Interval 90.0 to 295.0

SECONDARY outcome

Timeframe: From 20 months up to 48 months

Population: The analysis were performed on the primary analysis population, the Full Analysis Set population. Defined as the median duration of participants who achieved CR+CRi only

Duration was calculated by Kaplan- Meier estimates

Outcome measures

Measure	Clofarabine n=29 Participants Clofarabine 30 mg/m\^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m\^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
Duration of Complete Remission	63 days Interval 43.0 to 168.0

Adverse Events

Clofarabine

Serious events: 40 serious events

Other events: 66 other events

Deaths: 0 deaths

Serious adverse events

Measure	Clofarabine n=66 participants at risk Clofarabine 30 mg/m\^2/day intravenously over 1 hour for 5 days every 28 to 42 days(one cycle) and 20 mg/m\^2/day intravenously over 1 hour for 5 days every 29 to 43 days for second and subsequent cycles,up to a maximum of 3 cycles.
Blood and lymphatic system disorders ANAEMIA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Blood and lymphatic system disorders NEUTROPENIA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Blood and lymphatic system disorders PANCYTOPENIA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Blood and lymphatic system disorders PLATELET DISORDER	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Cardiac disorders ATRIAL FIBRILLATION	6.1% 4/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Cardiac disorders PERICARDIAL EFFUSION	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Endocrine disorders HYPOPITUITARISM	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders ABDOMINAL DISTENSION	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders DIARRHOEA	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders ILEUS PARALYTIC	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders VOMITING	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
General disorders DISEASE PROGRESSION	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
General disorders OEDEMA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
General disorders PYREXIA	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
General disorders SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations BACTERAEMIA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations BRONCHOPNEUMONIA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations CATHETER RELATED INFECTION	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations CENTRAL LINE INFECTION	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations ENCEPHALITIS HERPES	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations INFECTION	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations NEUTROPENIC SEPSIS	25.8% 17/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations PNEUMONIA	6.1% 4/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations RESPIRATORY TRACT INFECTION FUNGAL	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations SEPSIS	7.6% 5/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Injury, poisoning and procedural complications ACCIDENTAL OVERDOSE	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Injury, poisoning and procedural complications FALL	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BLOOD BILIRUBIN INCREASED	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BLOOD CREATININE INCREASED	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations HAEMOGLOBIN DECREASED	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations HEPATIC ENZYME INCREASED	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations URINE OUTPUT DECREASED	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Metabolism and nutrition disorders HYPOKALAEMIA	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Metabolism and nutrition disorders HYPOMAGNESAEMIA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Musculoskeletal and connective tissue disorders BACK PAIN	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PITUITARY TUMOUR	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders CEREBRAL HAEMORRHAGE	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders CEREBROVASCULAR ACCIDENT	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders HAEMORRHAGE INTRACRANIAL	4.5% 3/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders HEADACHE	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders SYNCOPE	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders UNRESPONSIVE TO PAIN STIMULI	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Renal and urinary disorders NEPHROTIC SYNDROME	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Renal and urinary disorders RENAL FAILURE ACUTE	10.6% 7/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Renal and urinary disorders RENAL IMPAIRMENT	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Renal and urinary disorders RENAL INSUFFICIENCY	7.6% 5/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Skin and subcutaneous tissue disorders RASH	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Skin and subcutaneous tissue disorders SKIN DESQUAMATION	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Vascular disorders HYPOTENSION	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Vascular disorders THROMBOSIS	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.

Other adverse events

Measure	Clofarabine n=66 participants at risk Clofarabine 30 mg/m\^2/day intravenously over 1 hour for 5 days every 28 to 42 days(one cycle) and 20 mg/m\^2/day intravenously over 1 hour for 5 days every 29 to 43 days for second and subsequent cycles,up to a maximum of 3 cycles.
Blood and lymphatic system disorders ANAEMIA	33.3% 22/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Blood and lymphatic system disorders COAGULOPATHY	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Blood and lymphatic system disorders DISSEMINATED INTRAVASCULAR COAGULATION	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	6.1% 4/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Blood and lymphatic system disorders HAEMOLYTIC ANAEMIA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Blood and lymphatic system disorders LYMPHOPENIA	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Blood and lymphatic system disorders NEUTROPENIA	28.8% 19/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Blood and lymphatic system disorders PANCYTOPENIA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Blood and lymphatic system disorders SPLENOMEGALY	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Blood and lymphatic system disorders THROMBOCYTOPENIA	48.5% 32/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Cardiac disorders ARRHYTHMIA SUPRAVENTRICULAR	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Cardiac disorders ATRIAL FIBRILLATION	6.1% 4/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Cardiac disorders PALPITATIONS	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Cardiac disorders SUPRAVENTRICULAR EXTRASYSTOLES	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Cardiac disorders TACHYCARDIA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Ear and labyrinth disorders VERTIGO	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Endocrine disorders ADRENAL INSUFFICIENCY	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Endocrine disorders HYPOTHALAMO-PITUITARY DISORDERS	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Endocrine disorders HYPOTHYROIDISM	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Eye disorders EYE PAIN	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Eye disorders EYE REDNESS	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Eye disorders HETEROPHORIA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Eye disorders KERATOCONJUNCTIVITIS SICCA	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Eye disorders LACRIMATION INCREASED	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Eye disorders VISION BLURRED	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders ABDOMINAL DISTENSION	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders ABDOMINAL PAIN	19.7% 13/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders CHEILITIS	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders CONSTIPATION	40.9% 27/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders DIARRHOEA	60.6% 40/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders DRY MOUTH	9.1% 6/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders DYSPEPSIA	7.6% 5/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders DYSPHAGIA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders ERUCTATION	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders FAECALOMA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders FLATULENCE	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders GINGIVAL PAIN	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders GLOSSODYNIA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders HAEMATEMESIS	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders HAEMORRHOIDAL HAEMORRHAGE	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders ILEUS PARALYTIC	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders LOOSE STOOLS	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders MELAENA	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders MOUTH ULCERATION	9.1% 6/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders NAUSEA	66.7% 44/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders OESOPHAGEAL ULCER	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders ORAL MUCOSAL BLISTERING	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders ORAL MUCOSAL PETECHIAE	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders ORAL PAIN	7.6% 5/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders RECTAL PROLAPSE	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders STOMATITIS	7.6% 5/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders SWOLLEN TONGUE	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders TONGUE BLISTERING	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders TONGUE COATED	4.5% 3/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders TONGUE ULCERATION	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders TOOTHACHE	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Gastrointestinal disorders VOMITING	56.1% 37/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
General disorders ASTHENIA	10.6% 7/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
General disorders CATHETER RELATED COMPLICATION	21.2% 14/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
General disorders CATHETER SITE INFLAMMATION	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
General disorders CHEST DISCOMFORT	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
General disorders CHEST PAIN	16.7% 11/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
General disorders FATIGUE	24.2% 16/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
General disorders GAIT ABNORMAL	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
General disorders GENERALISED OEDEMA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
General disorders INFLUENZA LIKE ILLNESS	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
General disorders LOCALISED OEDEMA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
General disorders MASS	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
General disorders MUCOSAL INFLAMMATION	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
General disorders OEDEMA	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
General disorders OEDEMA PERIPHERAL	18.2% 12/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
General disorders PAIN	4.5% 3/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
General disorders PITTING OEDEMA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
General disorders PYREXIA	36.4% 24/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
General disorders RIGORS	10.6% 7/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
General disorders TENDERNESS	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Hepatobiliary disorders CHOLELITHIASIS	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Hepatobiliary disorders HEPATOTOXICITY	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Hepatobiliary disorders HYPERBILIRUBINAEMIA	6.1% 4/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Immune system disorders HYPERSENSITIVITY	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations ANAL INFECTION	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations BACTERIAL INFECTION	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations BACTERIAL SEPSIS	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations CELLULITIS	10.6% 7/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations CENTRAL LINE INFECTION	16.7% 11/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations CLOSTRIDIAL INFECTION	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations CLOSTRIDIUM COLITIS	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations FUNGAL INFECTION	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations GASTROINTESTINAL CANDIDIASIS	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations GENITAL INFECTION FEMALE	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations HERPES SIMPLEX	4.5% 3/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations HERPES VIRUS INFECTION	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations INFECTION	13.6% 9/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	6.1% 4/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations NASOPHARYNGITIS	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations NEUTROPENIC INFECTION	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations NEUTROPENIC SEPSIS	4.5% 3/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations ORAL CANDIDIASIS	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations PHARYNGITIS	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations PNEUMONIA	4.5% 3/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations PNEUMONIA FUNGAL	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations RHINITIS	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations SEPSIS	7.6% 5/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations URINARY TRACT INFECTION	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations VANCOMYCIN-RESISTANT ENTEROCOCCAL INFECTION	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Infections and infestations VIRAL INFECTION	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Injury, poisoning and procedural complications BLISTER	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Injury, poisoning and procedural complications CONTUSION	6.1% 4/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Injury, poisoning and procedural complications FALL	4.5% 3/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Injury, poisoning and procedural complications MEDICAL DEVICE DISCOMFORT	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Injury, poisoning and procedural complications TRANSFUSION REACTION	4.5% 3/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations ALANINE AMINOTRANSFERASE INCREASED	31.8% 21/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	22.7% 15/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BACTERIA BLOOD IDENTIFIED	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BACTERIA STOOL IDENTIFIED	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BLOOD ALBUMIN DECREASED	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BLOOD ALKALINE PHOSPHATASE INCREASED	7.6% 5/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BLOOD BICARBONATE DECREASED	6.1% 4/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BLOOD BILIRUBIN INCREASED	9.1% 6/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BLOOD CALCIUM DECREASED	4.5% 3/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BLOOD CREATININE	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BLOOD CREATININE ABNORMAL	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BLOOD CREATININE DECREASED	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BLOOD CREATININE INCREASED	12.1% 8/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BLOOD LACTATE DEHYDROGENASE INCREASED	13.6% 9/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BLOOD MAGNESIUM	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BLOOD MAGNESIUM DECREASED	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BLOOD MAGNESIUM INCREASED	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BLOOD PHOSPHORUS DECREASED	4.5% 3/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BLOOD PHOSPHORUS INCREASED	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BLOOD POTASSIUM DECREASED	16.7% 11/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BLOOD PRESSURE DECREASED	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BLOOD SODIUM DECREASED	4.5% 3/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BLOOD SODIUM INCREASED	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BLOOD UREA DECREASED	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BLOOD UREA INCREASED	15.2% 10/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations BODY TEMPERATURE INCREASED	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations CARDIAC MURMUR	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations HAEMOGLOBIN DECREASED	9.1% 6/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations HEART RATE IRREGULAR	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations HEPATIC ENZYME INCREASED	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations LIVER FUNCTION TEST ABNORMAL	4.5% 3/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations NEUTROPHIL COUNT DECREASED	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations PLATELET COUNT DECREASED	9.1% 6/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations PROTEIN TOTAL DECREASED	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations PROTHROMBIN TIME PROLONGED	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations TROPONIN T INCREASED	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations URINE OUTPUT DECREASED	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations WEIGHT DECREASED	4.5% 3/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations WEIGHT INCREASED	6.1% 4/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Investigations WHITE BLOOD CELL COUNT DECREASED	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Metabolism and nutrition disorders ACIDOSIS	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Metabolism and nutrition disorders ANOREXIA	15.2% 10/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Metabolism and nutrition disorders DECREASED APPETITE	25.8% 17/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Metabolism and nutrition disorders DEHYDRATION	7.6% 5/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Metabolism and nutrition disorders ELECTROLYTE IMBALANCE	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Metabolism and nutrition disorders FLUID OVERLOAD	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Metabolism and nutrition disorders GOUT	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Metabolism and nutrition disorders HYPERGLYCAEMIA	6.1% 4/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Metabolism and nutrition disorders HYPERNATRAEMIA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Metabolism and nutrition disorders HYPERPHOSPHATAEMIA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Metabolism and nutrition disorders HYPOALBUMINAEMIA	9.1% 6/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Metabolism and nutrition disorders HYPOCALCAEMIA	16.7% 11/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Metabolism and nutrition disorders HYPOKALAEMIA	34.8% 23/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Metabolism and nutrition disorders HYPOMAGNESAEMIA	6.1% 4/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Metabolism and nutrition disorders HYPONATRAEMIA	4.5% 3/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Metabolism and nutrition disorders HYPOPHOSPHATAEMIA	4.5% 3/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Metabolism and nutrition disorders METABOLIC ACIDOSIS	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Musculoskeletal and connective tissue disorders ARTHRALGIA	10.6% 7/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Musculoskeletal and connective tissue disorders ARTHRITIS	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Musculoskeletal and connective tissue disorders BACK PAIN	9.1% 6/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Musculoskeletal and connective tissue disorders BUTTOCK PAIN	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Musculoskeletal and connective tissue disorders JOINT STIFFNESS	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Musculoskeletal and connective tissue disorders JOINT SWELLING	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Musculoskeletal and connective tissue disorders MUSCLE CRAMP	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Musculoskeletal and connective tissue disorders MYALGIA	7.6% 5/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Musculoskeletal and connective tissue disorders NECK PAIN	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	10.6% 7/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders BURNING SENSATION	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders CENTRAL NERVOUS SYSTEM INFLAMMATION	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders CEREBRAL ISCHAEMIA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders DEPRESSED LEVEL OF CONSCIOUSNESS	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders DIZZINESS	16.7% 11/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders DYSARTHRIA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders DYSGEUSIA	4.5% 3/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders HAEMORRHAGE INTRACRANIAL	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders HEADACHE	21.2% 14/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders HYPERAESTHESIA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders HYPOAESTHESIA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders LETHARGY	10.6% 7/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders PARAESTHESIA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders POLYNEUROPATHY	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders RESTLESS LEGS SYNDROME	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders SOMNOLENCE	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders SPEECH DISORDER	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders SYNCOPE	4.5% 3/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders SYNCOPE VASOVAGAL	4.5% 3/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Psychiatric disorders AGITATION	7.6% 5/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Psychiatric disorders ANXIETY	10.6% 7/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Psychiatric disorders CONFUSIONAL STATE	13.6% 9/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Psychiatric disorders DEPRESSED MOOD	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Psychiatric disorders DEPRESSION	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Psychiatric disorders DISORIENTATION	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Psychiatric disorders EMOTIONAL DISTRESS	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Psychiatric disorders HALLUCINATION	9.1% 6/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Psychiatric disorders INSOMNIA	13.6% 9/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Psychiatric disorders PANIC ATTACK	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Psychiatric disorders PSYCHIATRIC SYMPTOM	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Psychiatric disorders SLEEP DISORDER	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Renal and urinary disorders DYSURIA	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Renal and urinary disorders HAEMATURIA	7.6% 5/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Renal and urinary disorders OLIGURIA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Renal and urinary disorders POLLAKIURIA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Renal and urinary disorders RENAL COLIC	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Renal and urinary disorders RENAL FAILURE ACUTE	4.5% 3/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Renal and urinary disorders RENAL IMPAIRMENT	10.6% 7/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Renal and urinary disorders RENAL INSUFFICIENCY	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Renal and urinary disorders RENAL TUBULAR DISORDER	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Renal and urinary disorders URINARY INCONTINENCE	6.1% 4/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Reproductive system and breast disorders BALANITIS	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Reproductive system and breast disorders PENIS DISORDER	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Reproductive system and breast disorders VAGINAL HAEMORRHAGE	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Respiratory, thoracic and mediastinal disorders APNOEIC ATTACK	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Respiratory, thoracic and mediastinal disorders CAPILLARY LEAK SYNDROME	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Respiratory, thoracic and mediastinal disorders COUGH	19.7% 13/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Respiratory, thoracic and mediastinal disorders CRACKLES LUNG	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	21.2% 14/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	12.1% 8/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Respiratory, thoracic and mediastinal disorders HYPOXIA	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Respiratory, thoracic and mediastinal disorders INCREASED UPPER AIRWAY SECRETION	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Respiratory, thoracic and mediastinal disorders LUNG CREPITATION	9.1% 6/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Respiratory, thoracic and mediastinal disorders LUNG INFILTRATION	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Respiratory, thoracic and mediastinal disorders PHARYNGOLARYNGEAL PAIN	12.1% 8/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	9.1% 6/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Respiratory, thoracic and mediastinal disorders PLEURITIC PAIN	4.5% 3/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Respiratory, thoracic and mediastinal disorders RESPIRATORY DISORDER	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Respiratory, thoracic and mediastinal disorders WHEEZING	7.6% 5/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Skin and subcutaneous tissue disorders ALOPECIA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Skin and subcutaneous tissue disorders DECUBITUS ULCER	4.5% 3/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Skin and subcutaneous tissue disorders DERMATITIS ALLERGIC	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Skin and subcutaneous tissue disorders DERMATITIS EXFOLIATIVE	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Skin and subcutaneous tissue disorders DRY SKIN	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Skin and subcutaneous tissue disorders ECCHYMOSIS	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Skin and subcutaneous tissue disorders ERYTHEMA	10.6% 7/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Skin and subcutaneous tissue disorders HYPERHIDROSIS	4.5% 3/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Skin and subcutaneous tissue disorders LOCALISED SKIN REACTION	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Skin and subcutaneous tissue disorders NIGHT SWEATS	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Skin and subcutaneous tissue disorders PALMAR ERYTHEMA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Skin and subcutaneous tissue disorders PRURITUS	10.6% 7/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Skin and subcutaneous tissue disorders PRURITUS GENERALISED	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Skin and subcutaneous tissue disorders PURPURA	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Skin and subcutaneous tissue disorders RASH	43.9% 29/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Skin and subcutaneous tissue disorders RASH ERYTHEMATOUS	4.5% 3/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Skin and subcutaneous tissue disorders RASH GENERALISED	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Skin and subcutaneous tissue disorders RASH MACULAR	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Skin and subcutaneous tissue disorders RASH PAPULAR	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Skin and subcutaneous tissue disorders RASH PRURITIC	4.5% 3/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Skin and subcutaneous tissue disorders SWELLING FACE	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Social circumstances INADEQUATE DIET	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Vascular disorders FLUSHING	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Vascular disorders HAEMORRHAGE	3.0% 2/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Vascular disorders HYPERTENSION	10.6% 7/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Vascular disorders HYPOTENSION	16.7% 11/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Vascular disorders ORTHOSTATIC HYPOTENSION	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Vascular disorders PETECHIAE	7.6% 5/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.
Vascular disorders VENOUS THROMBOSIS LIMB	1.5% 1/66 • From first dose until 30 days after study completion (20 months) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (""number of affected participants"") of both adverse event tables.

Additional Information

Trial Transparency Team

Sanofi

Email: Contact-us@sanofi.com

Results disclosure agreements

• Principal investigator is a sponsor employee There IS an agreement between the Principal Investigator (PI) and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. In multi-site studies, PI can publish after sponsor publishes or 18 months after study completion. PI gives sponsor a draft 60 days before publication. Sponsor can ask that confidential information be removed, and can defer publication another 60 days upon notifying PI that it will file a patent application.
• Publication restrictions are in place

Restriction type: OTHER