Trial Outcomes & Findings for Rabbit Anti-thymocyte Globulin in the Treatment of Patients With Low to Intermediate-1 Risk Myelodysplastic Syndrome (NCT NCT00542828)

Last Updated: 2015-04-03

Results Overview

This is a measure of HI in the erythroid, platelet, and neutrophil lineages. Note that HI was observed in the erythroid lineage only, which is defined as a participant who had a \>=1.5 g/dL increase in hemoglobin from baseline (pretreatment value must have been \<11 g/dL) and who had a relevant reduction of units of red blood cell (RBC) transfusions by an absolute number of \>=4 RBC transfusions over 8 weeks as compared with the pretreatment transfusion number in the previous 8 weeks. These criteria were taken from the 2006 International Working Group criteria.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

12 months

Results posted on

2015-04-03

Participant Flow

Enrollment period: 05 November 2007 through 06 May 2009. Study participants were enrolled at 7 study centers in Europe.

Because the study was terminated early due to slow enrollment, only 16 participants were enrolled in the study. Of these, 14 participants went on to receive treatment with Thymoglobulin.

Participant milestones

Participant milestones
Measure	Thymoglobulin Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
Overall Study STARTED	16
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Thymoglobulin Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
Overall Study Physician Decision	1
Overall Study Need for Prohibited Treatment	3
Overall Study Study Prematurely Discontinued	7
Overall Study Did Not Receive Thymoglobulin Treatment	2

Baseline Characteristics

Rabbit Anti-thymocyte Globulin in the Treatment of Patients With Low to Intermediate-1 Risk Myelodysplastic Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Thymoglobulin n=14 Participants Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
Age, Continuous	55.4 years STANDARD_DEVIATION 7.67 • n=93 Participants
Age, Customized <60 years	10 participants n=93 Participants
Age, Customized >=60 years	4 participants n=93 Participants
Sex: Female, Male Female	7 Participants n=93 Participants
Sex: Female, Male Male	7 Participants n=93 Participants
Race/Ethnicity, Customized Black	1 participants n=93 Participants
Race/Ethnicity, Customized White	11 participants n=93 Participants
Race/Ethnicity, Customized Not Reported	2 participants n=93 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Number of participants analyzed includes those who received treatment with Thymoglobulin and completed follow-up efficacy assessments. However, no formal efficacy analysis was conducted due to the small sample size and early study termination.

Outcome measures

Outcome measures
Measure	Thymoglobulin n=13 Participants Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
Number of Participants Who Achieved Hematologic Improvement (HI)	3 participants

SECONDARY outcome

Timeframe: 36 months

Population: This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).

This is a measure of the duration of HI for those participants who achieved HI. Duration of HI is defined as the time from confirmation of HI response to the date of first documentation of HI relapse or death due to any cause, whichever occurs first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

Disease remission is defined as a participant whose best response to therapy was a complete remission or partial remission. A complete remission is defined as: bone marrow \<=5% myeloblasts with normal maturation of all cell lines; persistent dysplasia noted; and peripheral blood hemoglobin \>=11 g/dL, platelets \>=100 x 10\^9/L, neutrophils \>=1.0 x 10\^9/L, and blasts 0%. Partial remission is defined as: all complete remission criteria if abnormal before treatment, except bone marrow blasts decreased by \>=50% over pretreatment, but still \>5%; and cellularity and morphology not relevant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

This is a measure of the duration of overall disease remission only for those participants who achieved an overall remission. Duration of overall remission is defined as the time from first documentation of overall remission to the date of first documentation of disease relapse or death due to any cause, whichever occurs first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

This is a measure of transfusion independence, which is defined as a participant with no transfusions for a period of 8 consecutive calendar weeks after first dose. Transfusion independence was to be calculated only for those participants who had documented transfusions during the 8 weeks prior to enrollment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

This is a measure of the duration of transfusion independence only for those participants who achieved transfusion independence. Duration of transfusion independence is defined as the longest period of time during which a participant requires no transfusions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

This is a measure of relapse following HI, which is defined as a participant who experiences at least one of the following: \>=50% decrease from maximum response levels in granulocytes or platelets; \>=1.5 g/dL reduction in hemoglobin; or transfusion dependence.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

Population: Secondary outcome measure was not formally analyzed or assessed due to early study termination and small sample size (i.e., no study participants reached the 36-month time point)

This is a measure of relapse following an overall remission only for participants who experienced either a complete or partial remission. Relapse following an overall remission is defined as a participant who meets any of the following criteria: a return to pretreatment bone marrow blast percentage; decrease of \>=50% from maximum remission levels in neutrophils or platelets; reduction in hemoglobin concentration by \>=1.5 g/dL from maximum remission levels; or transfusion dependence.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

This is a measure of a progression-free survival which is defined as the time from the participant's first dose to the date of disease progression, lost to follow-up or death due to any cause, whichever occurs first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

This is a measure of transformation to acute myeloid leukemia only for participants who have bone marrow assessments. Transformation to acute myeloid leukemia is defined as the earliest date a participant experiences bone marrow blasts of \>=20% after the start of treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

This is a measure of cytogenic response for participants whose best response to therapy is a either a complete or partial cytogenetic response. A complete cytogenetic response is defined as the disappearance of the chromosomal abnormality without appearance of new ones. A partial cytogenetic response is defined as at least 50% reduction of the chromosomal abnormality.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

This is a measure of bone marrow complete remission for participants who experience a remission. Bone marrow complete remission is defined as a bone marrow assessment of \<=5% myeloblasts and decrease by \>=50% over pretreatment.

Outcome measures

Outcome data not reported

Adverse Events

Thymoglobulin

Serious events: 7 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Thymoglobulin n=14 participants at risk Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
Cardiac disorders Bradycardia	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Intestinal perforation	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 haemorrhage	14.3% 2/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Serum sickness	14.3% 2/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Influenza	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Myositis	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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) Myelodysplastic syndrome	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 embolism	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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

Other adverse events
Measure	Thymoglobulin n=14 participants at risk Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
Immune system disorders Serum sickness	21.4% 3/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Epstein-Barr virus infection	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Folliculitis	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Gastroenteritis	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Anaemia	14.3% 2/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	14.3% 2/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	14.3% 2/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Deafness	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Conjunctival haemorrhage	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Scleral hyperaemia	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Visual impairment	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	14.3% 2/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 tenderness	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	71.4% 10/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	21.4% 3/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 haemorrhage	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	35.7% 5/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 haemorrhage	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	28.6% 4/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 pain	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Chills	21.4% 3/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	21.4% 3/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Injection site reaction	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Local swelling	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Non-cardiac chest pain	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	21.4% 3/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	64.3% 9/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Cytokine release syndrome	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	14.3% 2/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Staphylococcal infection	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Upper respiratory tract infection	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 glucose increased	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 urine present	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	14.3% 2/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 urine present	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	14.3% 2/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	21.4% 3/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	28.6% 4/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	35.7% 5/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Bone pain	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Flank pain	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 spasms	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 chest pain	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	21.4% 3/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 jaw	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Benign intracranial hypertension	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	42.9% 6/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	21.4% 3/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	14.3% 2/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Tremor	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Genital ulceration	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Menorrhagia	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Menstrual disorder	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Sexual dysfunction	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	14.3% 2/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	28.6% 4/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Oropharyngeal pain	21.4% 3/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	14.3% 2/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	14.3% 2/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Eczema	14.3% 2/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Pain of skin	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Petechiae	14.3% 2/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	14.3% 2/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	35.7% 5/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	14.3% 2/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	14.3% 2/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 chapped	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 exfoliation	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 lesion	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Stasis dermatitis	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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 Cardiovascular insufficiency	7.1% 1/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	14.3% 2/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	21.4% 3/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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	28.6% 4/14 • Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study). In the event a single participant has experienced both a serious and a non-serious 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

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