Trial Outcomes & Findings for Study of the Safety and Tolerability of PCI-24781 in Patients With Lymphoma (NCT NCT00724984)
NCT ID: NCT00724984
Last Updated: 2014-04-07
Results Overview
Number of patients experienced DLT in each cohort
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
55 participants
Primary outcome timeframe
From the Date of PCI-24781 first administration to Cycle 2 Day 1
Results posted on
2014-04-07
Participant Flow
Participant milestones
| Measure |
Cohort 1(30mg/m2,5days/wk)/Phase 1
|
Cohort 2(45mg/m2,5days/wk)/Phase 1
|
Cohort 3(45mg/m2,7days/wk)/Phase 1
|
Cohort 4(60mg/m2,7days/wk)/Phase 1
|
Follicular/Phase II
|
Mantle Cell Lymphoma/Phase II
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
8
|
3
|
9
|
16
|
14
|
|
Overall Study
COMPLETED
|
4
|
7
|
3
|
7
|
12
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
2
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Safety and Tolerability of PCI-24781 in Patients With Lymphoma
Baseline characteristics by cohort
| Measure |
Cohort 1(30 mg/m2, 5days/wk)/Phase 1
n=5 Participants
|
Cohort 2(45 mg/m2, 5days/wk)/Phase 1
n=8 Participants
|
Cohort 3(45 mg/m2, 7days/wk)/Phase 1
n=3 Participants
|
Cohort 4(60 mg/m2,7days/wk)/Phase 1
n=9 Participants
|
Follicular/Phase II
n=16 Participants
|
Mantle Cell Lymphoma/Phase II
n=14 Participants
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
67 years
n=7 Participants
|
62 years
n=5 Participants
|
66 years
n=4 Participants
|
62 years
n=21 Participants
|
67 years
n=8 Participants
|
66 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
30 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
25 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
3 participants
n=5 Participants
|
9 participants
n=4 Participants
|
16 participants
n=21 Participants
|
14 participants
n=8 Participants
|
55 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From the Date of PCI-24781 first administration to Cycle 2 Day 1Number of patients experienced DLT in each cohort
Outcome measures
| Measure |
Cohort 1(30 mg/m2, BID, 5days/wk)/Phase I
n=3 Participants
|
Cohort 2(45 mg/m2, BID, 5days/wk)/Phase I
n=7 Participants
|
Cohort 3(45 mg/m2, BID, 7days/wk)/Phase I
n=3 Participants
|
Cohort 4(60 mg/m2, BID, 7days/wk)/Phase I
n=8 Participants
|
|---|---|---|---|---|
|
Phase I (Dose Escalation Phase): MTD and DLTs of PCI-24781 Administered Twice Daily (BID) Measure: Disease Response
|
0 participants
|
3 participants
|
0 participants
|
2 participants
|
PRIMARY outcome
Timeframe: From first response assessment (day 22 to 28 of Cycle 2) to last response assessment on day 22-28 in even-numbered cyclesOutcome measures
| Measure |
Cohort 1(30 mg/m2, BID, 5days/wk)/Phase I
n=16 Participants
|
Cohort 2(45 mg/m2, BID, 5days/wk)/Phase I
n=14 Participants
|
Cohort 3(45 mg/m2, BID, 7days/wk)/Phase I
|
Cohort 4(60 mg/m2, BID, 7days/wk)/Phase I
|
|---|---|---|---|---|
|
Phase II: Overall Response Rate (CR+PR)
|
56.3 Percentage of Participants
Interval 29.9 to 80.2
|
21.4 Percentage of Participants
Interval 4.66 to 50.8
|
—
|
—
|
Adverse Events
Cohort 1(30 mg/m2, 5days/wk)/Phase I
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2(45 mg/m2, 5days/wk)/Phase I
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 3(45 mg/m2, 7days/wk)/Phase I
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4(60 mg/m2,7days/wk)/Phase I
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Follicular/Phase II
Serious events: 6 serious events
Other events: 16 other events
Deaths: 0 deaths
Mantle Cell Lymphoma/Phase II
Serious events: 5 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1(30 mg/m2, 5days/wk)/Phase I
n=5 participants at risk
|
Cohort 2(45 mg/m2, 5days/wk)/Phase I
n=8 participants at risk
|
Cohort 3(45 mg/m2, 7days/wk)/Phase I
n=3 participants at risk
|
Cohort 4(60 mg/m2,7days/wk)/Phase I
n=9 participants at risk
|
Follicular/Phase II
n=16 participants at risk
|
Mantle Cell Lymphoma/Phase II
n=14 participants at risk
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Gastrointestinal disorders
DIARRHOEA
|
20.0%
1/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Gastrointestinal disorders
HAEMORRHOIDAL HAEMORRHAGE
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Gastrointestinal disorders
MELAENA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Gastrointestinal disorders
NAUSEA
|
20.0%
1/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Gastrointestinal disorders
VOMITING
|
20.0%
1/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
General disorders
FATIGUE
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
General disorders
PERFORMANCE STATUS DECREASED
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
General disorders
PYREXIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Infections and infestations
ANAL ABSCESS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Infections and infestations
ANAL INFECTION
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Investigations
BLOOD CREATININE INCREASED
|
20.0%
1/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
20.0%
1/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER PAIN
|
20.0%
1/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOMA
|
20.0%
1/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM MALIGNANT
|
20.0%
1/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Nervous system disorders
ENCEPHALITIS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Renal and urinary disorders
ANURIA
|
20.0%
1/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
20.0%
1/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
Other adverse events
| Measure |
Cohort 1(30 mg/m2, 5days/wk)/Phase I
n=5 participants at risk
|
Cohort 2(45 mg/m2, 5days/wk)/Phase I
n=8 participants at risk
|
Cohort 3(45 mg/m2, 7days/wk)/Phase I
n=3 participants at risk
|
Cohort 4(60 mg/m2,7days/wk)/Phase I
n=9 participants at risk
|
Follicular/Phase II
n=16 participants at risk
|
Mantle Cell Lymphoma/Phase II
n=14 participants at risk
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
20.0%
1/5
|
12.5%
1/8
|
0.00%
0/3
|
22.2%
2/9
|
25.0%
4/16
|
28.6%
4/14
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
12.5%
2/16
|
7.1%
1/14
|
|
Blood and lymphatic system disorders
LYMPH NODE PAIN
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
7.1%
1/14
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
22.2%
2/9
|
25.0%
4/16
|
21.4%
3/14
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/5
|
50.0%
4/8
|
0.00%
0/3
|
22.2%
2/9
|
62.5%
10/16
|
28.6%
4/14
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Ear and labyrinth disorders
EAR PAIN
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Eye disorders
CONJUNCTIVITIS
|
0.00%
0/5
|
0.00%
0/8
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Eye disorders
DRY EYE
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Eye disorders
EYE SWELLING
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Eye disorders
EYELID IRRITATION
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Eye disorders
LACRIMATION INCREASED
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Eye disorders
MIOSIS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
12.5%
2/16
|
7.1%
1/14
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
40.0%
2/5
|
50.0%
4/8
|
0.00%
0/3
|
0.00%
0/9
|
18.8%
3/16
|
14.3%
2/14
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
7.1%
1/14
|
|
Gastrointestinal disorders
APHTHOUS STOMATITIS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Gastrointestinal disorders
CHAPPED LIPS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Gastrointestinal disorders
CONSTIPATION
|
20.0%
1/5
|
12.5%
1/8
|
0.00%
0/3
|
11.1%
1/9
|
43.8%
7/16
|
21.4%
3/14
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/5
|
37.5%
3/8
|
0.00%
0/3
|
55.6%
5/9
|
50.0%
8/16
|
50.0%
7/14
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
12.5%
2/16
|
0.00%
0/14
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/5
|
25.0%
2/8
|
0.00%
0/3
|
0.00%
0/9
|
18.8%
3/16
|
7.1%
1/14
|
|
Gastrointestinal disorders
ERUCTATION
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/5
|
0.00%
0/8
|
33.3%
1/3
|
0.00%
0/9
|
12.5%
2/16
|
14.3%
2/14
|
|
Gastrointestinal disorders
FREQUENT BOWEL MOVEMENTS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/5
|
25.0%
2/8
|
0.00%
0/3
|
0.00%
0/9
|
25.0%
4/16
|
7.1%
1/14
|
|
Gastrointestinal disorders
GLOSSODYNIA
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/5
|
37.5%
3/8
|
33.3%
1/3
|
22.2%
2/9
|
68.8%
11/16
|
50.0%
7/14
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
7.1%
1/14
|
|
Gastrointestinal disorders
RETCHING
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
18.8%
3/16
|
7.1%
1/14
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
22.2%
2/9
|
43.8%
7/16
|
21.4%
3/14
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/16
|
7.1%
1/14
|
|
General disorders
CHEST PAIN
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
General disorders
CHILLS
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
11.1%
1/9
|
6.2%
1/16
|
35.7%
5/14
|
|
General disorders
EARLY SATIETY
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
7.1%
1/14
|
|
General disorders
FATIGUE
|
80.0%
4/5
|
75.0%
6/8
|
33.3%
1/3
|
22.2%
2/9
|
62.5%
10/16
|
57.1%
8/14
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
General disorders
LOCALISED OEDEMA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
11.1%
1/9
|
12.5%
2/16
|
35.7%
5/14
|
|
General disorders
PAIN
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
General disorders
PERFORMANCE STATUS DECREASED
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
7.1%
1/14
|
|
General disorders
PYREXIA
|
20.0%
1/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
18.8%
3/16
|
7.1%
1/14
|
|
General disorders
VESSEL PUNCTURE SITE HAEMATOMA
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Hepatobiliary disorders
JAUNDICE
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Immune system disorders
ALLERGY TO ARTHROPOD BITE
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Infections and infestations
CANDIDIASIS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Infections and infestations
FUNGAL INFECTION
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Infections and infestations
INFECTED BITES
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Infections and infestations
OTITIS MEDIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Infections and infestations
PNEUMONIA KLEBSIELLA
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
12.5%
2/16
|
28.6%
4/14
|
|
Infections and infestations
STAPHYLOCOCCAL SKIN INFECTION
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Infections and infestations
TOOTH INFECTION
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
20.0%
1/5
|
0.00%
0/8
|
66.7%
2/3
|
0.00%
0/9
|
18.8%
3/16
|
14.3%
2/14
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
ANIMAL BITE
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
12.5%
2/16
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
12.5%
2/16
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
12.5%
2/16
|
0.00%
0/14
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
7.1%
1/14
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Investigations
BLOOD BICARBONATE DECREASED
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
7.1%
1/14
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Investigations
BREATH SOUNDS ABNORMAL
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
12.5%
2/16
|
0.00%
0/14
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Investigations
ELECTROCARDIOGRAM ST-T CHANGE
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Investigations
HAEMOGLOBIN
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Investigations
HEART RATE INCREASED
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Investigations
TROPONIN INCREASED
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
6.2%
1/16
|
7.1%
1/14
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
22.2%
2/9
|
25.0%
4/16
|
21.4%
3/14
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
18.8%
3/16
|
14.3%
2/14
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
20.0%
1/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
18.8%
3/16
|
14.3%
2/14
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
HYPERLIPIDAEMIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
HYPERNATRAEMIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
6.2%
1/16
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
12.5%
2/16
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
12.5%
2/16
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
12.5%
2/16
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
11.1%
1/9
|
18.8%
3/16
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
INCREASED APPETITE
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
12.5%
2/16
|
14.3%
2/14
|
|
Musculoskeletal and connective tissue disorders
ARTHROPATHY
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
14.3%
2/14
|
|
Musculoskeletal and connective tissue disorders
CLUBBING
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
COSTOCHONDRITIS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
GROIN PAIN
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
JOINT STIFFNESS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
LIMB DISCOMFORT
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
11.1%
1/9
|
12.5%
2/16
|
14.3%
2/14
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
14.3%
2/14
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL DISCOMFORT
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/5
|
25.0%
2/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
SPINAL COLUMN STENOSIS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Nervous system disorders
AREFLEXIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Nervous system disorders
ATAXIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/5
|
37.5%
3/8
|
0.00%
0/3
|
22.2%
2/9
|
18.8%
3/16
|
7.1%
1/14
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
25.0%
4/16
|
21.4%
3/14
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
11.1%
1/9
|
31.2%
5/16
|
21.4%
3/14
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Nervous system disorders
HYPOGEUSIA
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Nervous system disorders
INTENTION TREMOR
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
22.2%
2/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Nervous system disorders
MOTOR DYSFUNCTION
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Nervous system disorders
PAROSMIA
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
18.8%
3/16
|
7.1%
1/14
|
|
Nervous system disorders
TENSION HEADACHE
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Nervous system disorders
TREMOR
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
12.5%
2/16
|
7.1%
1/14
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
31.2%
5/16
|
7.1%
1/14
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Renal and urinary disorders
MICTURITION URGENCY
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Renal and urinary disorders
NOCTURIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
7.1%
1/14
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
11.1%
1/9
|
37.5%
6/16
|
50.0%
7/14
|
|
Respiratory, thoracic and mediastinal disorders
DRY THROAT
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/5
|
37.5%
3/8
|
0.00%
0/3
|
22.2%
2/9
|
6.2%
1/16
|
28.6%
4/14
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
12.5%
2/16
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
NASAL ULCER
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
OBLITERATIVE BRONCHIOLITIS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
12.5%
2/16
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
PARANASAL SINUS HYPERSECRETION
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
11.1%
1/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY CONGESTION
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
RALES
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY TRACT OEDEMA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
14.3%
2/14
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
UPPER-AIRWAY COUGH SYNDROME
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
12.5%
2/16
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
11.1%
1/9
|
12.5%
2/16
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/5
|
25.0%
2/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/5
|
25.0%
2/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
INCREASED TENDENCY TO BRUISE
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
ONYCHOCLASIS
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
PETECHIAE
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
20.0%
1/5
|
25.0%
2/8
|
0.00%
0/3
|
0.00%
0/9
|
12.5%
2/16
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
PRURITUS GENERALISED
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
11.1%
1/9
|
6.2%
1/16
|
21.4%
3/14
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
SEBORRHOEIC DERMATITIS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
SKIN BURNING SENSATION
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/5
|
0.00%
0/8
|
33.3%
1/3
|
0.00%
0/9
|
6.2%
1/16
|
0.00%
0/14
|
|
Vascular disorders
FLUSHING
|
0.00%
0/5
|
0.00%
0/8
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Vascular disorders
HOT FLUSH
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
12.5%
2/16
|
0.00%
0/14
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
6.2%
1/16
|
7.1%
1/14
|
|
Vascular disorders
JUGULAR VEIN THROMBOSIS
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
7.1%
1/14
|
|
Vascular disorders
PERIPHERAL COLDNESS
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/16
|
0.00%
0/14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place